Identity
- Trade Name
- MEDPOR FDA UDI
- Generic Name
- Malar prosthesis FDA UDI
- Device Name
- Midface Contour Implant - Reconstructive - Left with Sizing Template FDA UDI
- Model / Reference
- 92-83007 FDA UDI
- Description
- Midface Contour Implant - Reconstructive - Left with Sizing Template FDA UDI
Identifiers
- Catalog Number
- 92-83007 FDA UDI
- Primary DI / UDI-DI
- 07613252615804 FDA UDI
- 510(k) Number
- K922489 FDA UDI
- FDA Product Code
- FWP FDA UDI
- GMDN Term
- Malar prosthesis 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
- Height — 41.0 Millimeter FDA UDILength — 65.0 Millimeter FDA UDI
Category: Malar prosthesis
Medpor by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Malar prosthesis.
- Binder Submalar® — Implantech Associates, Inc. · Class II
- Conform Binder Submalar® — Implantech Associates, Inc. · Class II
- Conform™ Midfacial — Implantech Associates, Inc. · Class II
- Malar Implant — Hanson Medical, Inc. · Class II
- Conform™ Midfacial — Implantech Associates, Inc. · Class II
- Malar Implant — Hanson Medical, Inc. · Class II
- Malar Implant — Implantech Associates, Inc. · Class II
- 900-014 Profile Malar Sizer Set — Implantech Associates, Inc. · 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 353f4ce9-2438-4d9f-b9d3-2dbeb4d16264 36 fields · synced Jun 8, 2026