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INFUSE® Bone Graft 7510600

by Medtronic Sofamor Danek, Inc. United States GUDID

Product code NPZ

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00681490843812 UDI-DIDate23 Sep 2014ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

8 recalls · FDA

    • Terminated Z-0440-2019 FDA Class II initiated 27 Sep 2018

    The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

  • 7 recalls, same reason

    • Terminated Z-1591-2013 FDA Class II initiated 28 May 2013
    • Terminated Z-1589-2013 FDA Class II initiated 28 May 2013
    • Terminated Z-1590-2013 FDA Class II initiated 28 May 2013
    • Terminated Z-1592-2013 FDA Class II initiated 28 May 2013
    • Terminated Z-1594-2013 FDA Class II initiated 28 May 2013
    • Terminated Z-1595-2013 FDA Class II initiated 28 May 2013
    • Terminated Z-1593-2013 FDA Class II initiated 28 May 2013

    Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Specification

GUDID · synced 22 Oct 2026

Trade Name
INFUSE® Bone Graft
Generic Name
Spinal fusion graft kit
Model / Reference
7510600
Primary DI / UDI-DI
00681490843812
PMA Number
FDA Product Code
NPZ, NEK
GMDN Term
Spinal fusion graft kit
Device Class
Class III
Regulation Number
872.3930
Commercial Distribution
In Commercial Distribution

Related devices

Category: Spinal fusion graft kit

Cleared under the same submission (P000058)

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Implantable
  • Prescription Use
  • Combination Product
  • Lot / Batch Number
Other properties (9)
  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI c46d1fae-1a6c-40e7-a340-f28a20de46e1 37 fields · synced 22 Oct 2026