Identity
- Trade Name
- Restoration FDA UDI
- Generic Name
- Metallic acetabulum prosthesis FDA UDI
- Device Name
- Acetabular Wedge Augment FDA UDI
- Model / Reference
- 5096-6225 FDA UDI
- Description
- Acetabular Wedge Augment FDA UDI
Identifiers
- Catalog Number
- 5096-6225 FDA UDI
- Primary DI / UDI-DI
- 07613327019841 FDA UDI
- 510(k) Number
- K102019 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Metallic acetabulum prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 64.0 Millimeter FDA UDIOuter Diameter — 62.0 Millimeter FDA UDI
Category: Metallic acetabulum prosthesis
Restoration by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic acetabulum prosthesis.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc. · Class II
- Lineage — MicroPort Orthopedics Inc. · Class II
- Lineage — MicroPort Orthopedics Inc. · Class II
- Dynasty — MicroPort Orthopedics Inc. · Class II
- Platform Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- PRIME — MicroPort Orthopedics Inc. · Class II
- PROCOTYL® PRIME — MicroPort Orthopedics Inc. · Class II
- Lineage — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K102019 also covers:
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
- Restoration — Howmedica Osteonics Corp.
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 |
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Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI fc45cee7-9c83-41e1-bfd5-28f3dcc42c05 36 fields · synced Jun 8, 2026