Identity
- Trade Name
- GPS Advanced FDA UDI
- Generic Name
- Bone graft delivery kit FDA UDI
- Device Name
- GPS Advanced, Spine FDA UDI
- Model / Reference
- 84001000 FDA UDI
- Description
- GPS Advanced, Spine FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856879006960 FDA UDI
- 510(k) Number
- K251648 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Bone graft delivery kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone graft delivery kit
GPS Advanced by Prosidyan, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone graft delivery kit.
- SCP® — Zimmer Knee Creations, Inc. · Class I
- SCP® — Zimmer Knee Creations, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- SCP® PF Foot & Ankle Kit — Zimmer Knee Creations, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- SCP® — Zimmer Knee Creations, Inc. · Class I
Cleared under the same submission
K251648 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prosidyan, Inc.
Sources (1)
- FDA UDI 97a6376c-9aa8-4ed6-b12e-269d6f300a71 34 fields · synced May 30, 2026