ISO 13485
Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2003 This is to certify that:
Pioneer Surgical Technology Inc. 375 River Park Circle Marquette Michigan 49855 USA
Holds Certificate No:
FM 72889
and operates a Quality Management System which complies with the requirements of ISO 13485:2003 for the following scope: The design, development, manufacture and servicing of sterile and non-sterile, biological, nonresorbable and resorbable orthopedic and spinal implants and instruments that include such product families as spinal fusion, spinal arthroplasty, orthopedic retention, fracture fixation and sternal cable systems, including product category Greater Trochanteric Reattachment Device (GTR). The design, development and manufacture of bone graft substitute utilizing synthetic powders and animal tissue.
For and on behalf of BSI: Reg Blake, VP Regulatory Affairs, BSI Group America Inc. Original Registration Date: 02/13/2003
Effective Date: 06/18/2015
Expiry Date: 12/01/2017
Page: 1 of 2
This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory To be read in conjunction with the scope above or the attached appendix. Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.
Certificate No:
FM 72889
Location
Registered Activities
Pioneer Surgical Technology Inc. 375 River Park Circle Marquette Michigan 49855 USA
The design, development, manufacture and servicing of sterile and non-sterile, biological, non-resorbable and resorbable orthopedic and spinal implants and instuments that include such product families as spinal fusion, spinal arthroplasty, orthopedic retention, fracture fixation and sternal cable systems, including product category Greater Trochanteric Reattachment Device (GTR).
Pioneer Surgical Technology Inc. 1800 A North Greene St. Greenville North Carolina 27834 USA
The design, development and manufacture of resorbable spinal and orthopedic bone graft substitutes utilizing synthetic powders and animal tissue materials and of nonresorbable spinal implants containing synthetic powders. The design and development of ancillary instrumentation.
Pioneer Surgical Technology Inc. 9600 Great Hills Trail, Suite 160E Austin Texas 78759 USA
The design and development of sterile and non-sterile, biological, non-resorbable and resorbable orthopedic and spinal implants and instruments that include such product families as spinal fusion, spinal arthroplasty, orthopedic retention, fracture fixation and sternal cable systems, including product category Greater Trochanteric Reattachment Device (GTR).
Pioneer Surgical Technology B.V. Voorveste 7 3992 DC Houten Netherlands
The design and manufacture of spinal implants. The distribution of sterile and non-sterile, biological, nonresorbable and resorbable orthopedic and spinal implants and instruments that include such product families as spinal fusion, spinal arthroplasty, orthopedic retention, fracture fixation and sternal cable systems, including product category Greater Trochanteric Reattachment Device (GTR).
Original Registration Date: 02/13/2003
Effective Date: 06/18/2015
Expiry Date: 12/01/2017 Page: 2 of 2
This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory To be read in conjunction with the scope above or the attached appendix. Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.
Pioneer Surgical Technology Inc. 375 River Park Circle Marquette Michigan 49855 USA
Holds Certificate No:
FM 72889
and operates a Quality Management System which complies with the requirements of ISO 13485:2003 for the following scope: The design, development, manufacture and servicing of sterile and non-sterile, biological, nonresorbable and resorbable orthopedic and spinal implants and instruments that include such product families as spinal fusion, spinal arthroplasty, orthopedic retention, fracture fixation and sternal cable systems, including product category Greater Trochanteric Reattachment Device (GTR). The design, development and manufacture of bone graft substitute utilizing synthetic powders and animal tissue.
For and on behalf of BSI: Reg Blake, VP Regulatory Affairs, BSI Group America Inc. Original Registration Date: 02/13/2003
Effective Date: 06/18/2015
Expiry Date: 12/01/2017
Page: 1 of 2
This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory To be read in conjunction with the scope above or the attached appendix. Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.
Certificate No:
FM 72889
Location
Registered Activities
Pioneer Surgical Technology Inc. 375 River Park Circle Marquette Michigan 49855 USA
The design, development, manufacture and servicing of sterile and non-sterile, biological, non-resorbable and resorbable orthopedic and spinal implants and instuments that include such product families as spinal fusion, spinal arthroplasty, orthopedic retention, fracture fixation and sternal cable systems, including product category Greater Trochanteric Reattachment Device (GTR).
Pioneer Surgical Technology Inc. 1800 A North Greene St. Greenville North Carolina 27834 USA
The design, development and manufacture of resorbable spinal and orthopedic bone graft substitutes utilizing synthetic powders and animal tissue materials and of nonresorbable spinal implants containing synthetic powders. The design and development of ancillary instrumentation.
Pioneer Surgical Technology Inc. 9600 Great Hills Trail, Suite 160E Austin Texas 78759 USA
The design and development of sterile and non-sterile, biological, non-resorbable and resorbable orthopedic and spinal implants and instruments that include such product families as spinal fusion, spinal arthroplasty, orthopedic retention, fracture fixation and sternal cable systems, including product category Greater Trochanteric Reattachment Device (GTR).
Pioneer Surgical Technology B.V. Voorveste 7 3992 DC Houten Netherlands
The design and manufacture of spinal implants. The distribution of sterile and non-sterile, biological, nonresorbable and resorbable orthopedic and spinal implants and instruments that include such product families as spinal fusion, spinal arthroplasty, orthopedic retention, fracture fixation and sternal cable systems, including product category Greater Trochanteric Reattachment Device (GTR).
Original Registration Date: 02/13/2003
Effective Date: 06/18/2015
Expiry Date: 12/01/2017 Page: 2 of 2
This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectory To be read in conjunction with the scope above or the attached appendix. Americas Headquarters: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.
