Certificate of Registration QUALITY MANAGEMENT SYSTEM – ISO 13485:2016 This is to certify that: DUNS Number: 15-738-4306 Holds certificate No: MDSAP 680421 Statement of Conformity: The company listed on this certificate has been audited to and found to conform with the following criteria: ISO 13485:2016 and Canada - Medical Devices Regulations - Part 1- SOR 98/282; USA - 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D For and on behalf of BSI: ____________________________________________________ Carlos Pitanga, Chief Operating Officer Assurance - Americas Original Registration Date: 2018-07-17 Effective Date: 2018-07-17 Expiry date: 2021-07-16 Page: 1 of 2 Osteotech, Inc. a subsidiary of Medtronic, Inc. 201 Industrial Way West Eatontown New Jersey 07724 USA Processing of human bone and connective tissue for transplantation and the design and development, manufacturing and marketing of biologic, biomaterial and device systems for musculoskeletal surgery. This certificate remains the property of BSI and shall be returned immediately upon request. To be read in conjunction with the scope above or the attached appendix. Managed by: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.

Certificate of Registration · Holds certificate No: MDSAP 680421 Statement of Conformity: The company listed on this certificate has been audited to and found to conform with the

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Certificate of Registration

QUALITY MANAGEMENT SYSTEM – ISO 13485:2016

This is to certify that:

DUNS Number: 15-738-4306

Holds certificate No: MDSAP 680421

Statement of Conformity: The company listed on this certificate has been audited to and found to conform with the

following criteria: ISO 13485:2016 and Canada - Medical Devices Regulations - Part 1- SOR 98/282; USA - 21 CFR 820, 21

CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D

For and on behalf of BSI: ____________________________________________________

Carlos Pitanga, Chief Operating Officer Assurance - Americas

Original Registration Date: 2018-07-17 Effective Date: 2018-07-17 Expiry date: 2021-07-16

Page: 1 of 2

Osteotech, Inc.

a subsidiary of Medtronic, Inc.

201 Industrial Way West

Eatontown

New Jersey

07724

USA

Processing of human bone and connective tissue for transplantation and the design and

development, manufacturing and marketing of biologic, biomaterial and device systems for

musculoskeletal surgery.

This certificate remains the property of BSI and shall be returned immediately upon request. To be read in conjunction with the scope above or the attached appendix. Managed by: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.

Page 2: Certificate of Registration · Holds certificate No: MDSAP 680421 Statement of Conformity: The company listed on this certificate has been audited to and found to conform with the

Location Registered Activities

Osteotech, Inc.

a subsidiary of Medtronic, Inc.

201 Industrial Way West

Eatontown

New Jersey

07724

USA

DUNS Number: 60-702-1003

Processing of human bone and connective tissue for transplantation

and the design and development, manufacturing and marketing of

biologic, biomaterial and device systems for musculoskeletal surgery.

Osteotech, Inc.

51 James Way

Eatontown

New Jersey

07724

USA

Local administration and warehouse functions.

Certificate No: MDSAP 680421

Original Registration Date: 2018-07-17 Effective Date: 2018-07-17 Expiry date: 2021-07-16

Page: 2 of 2 This certificate remains the property of BSI and shall be returned immediately upon request. To be read in conjunction with the scope above or the attached appendix. Managed by: BSI Group America Inc., 12950 Worldgate Drive, Suite 800, Herndon, VA 20170-6007 USA A Member of the BSI Group of Companies.