Identity
- Trade Name
- MEDPOR FDA UDI
- Generic Name
- Polyethylene craniofacial tissue reconstructive material FDA UDI
- Device Name
- Craniotomy Gap Wedge V <(>&<)> T FDA UDI
- Model / Reference
- 82011 FDA UDI
- Description
- Craniotomy Gap Wedge V <(>&<)> T FDA UDI
Identifiers
- Catalog Number
- 82011 FDA UDI
- Primary DI / UDI-DI
- 07613252084730 FDA UDI
- 510(k) Number
- K922489 FDA UDI
- FDA Product Code
- FWP FDA UDI
- GMDN Term
- Polyethylene craniofacial tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 102.0 Millimeter FDA UDI
Category: Polyethylene craniofacial tissue reconstructive material
Medpor by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene craniofacial tissue reconstructive material.
- Biopor® — Ceremed , Inc. · Class II
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- OmniPore Surgical Implant — MATRIX SURGICAL HOLDINGS, LLC · Class II
- OmniPore Surgical Implant Cutting Guide — MATRIX SURGICAL HOLDINGS, LLC · Class II
- Biopor® — Ceremed , Inc. · Class II
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
- SynPOR — Synthes · Class II
Cleared under the same submission
K922489 also covers:
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
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
- Stryker Leibinger
Sources (1)
- FDA UDI c291b15f-f109-4758-95e0-19a45160b734 36 fields · synced May 30, 2026