Identity
- Trade Name
- System 12 FDA UDI
- Generic Name
- Constrained polyethylene acetabular liner FDA UDI
- Device Name
- Constrained Acetabular Insert FDA UDI
- Model / Reference
- 6302-N-732 FDA UDI
- Description
- Constrained Acetabular Insert FDA UDI
Identifiers
- Catalog Number
- 6302-N-732 FDA UDI
- Primary DI / UDI-DI
- 07613327139150 FDA UDI
- 510(k) Number
- K063550 FDA UDI
- FDA Product Code
- KWZ FDA UDI
- GMDN Term
- Constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3310 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 32.0 Millimeter FDA UDI
Category: Constrained polyethylene acetabular liner
System 12 by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Constrained polyethylene acetabular liner.
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- DURALOC — DEPUY ORTHOPAEDICS, INC. · Class II
- Novation — Exactech, Inc. · Class II
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Cleared under the same submission
K063550 also covers:
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — Howmedica Osteonics Corp.
- System 12 — 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 0264b3dd-02bf-4078-aee6-a672c857f237 36 fields · synced Jun 8, 2026