Identity
- Trade Name
- Trident FDA UDI
- Generic Name
- Constrained polyethylene acetabular liner FDA UDI
- Device Name
- 0 Degree Eccentric Insert FDA UDI
- Model / Reference
- 663-00-36F FDA UDI
- Description
- 0 Degree Eccentric Insert FDA UDI
Identifiers
- Catalog Number
- 663-00-36F FDA UDI
- Primary DI / UDI-DI
- 07613327024708 FDA UDI
- 510(k) Number
- K033716 FDA UDI
- FDA Product Code
- MEH FDA UDILZO FDA UDIJDI FDA UDILPH FDA UDILWJ FDA UDI
- GMDN Term
- Constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3350 FDA UDI888.3358 FDA UDI888.3360 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 — 36.0 Millimeter FDA UDI
Category: Constrained polyethylene acetabular liner
Trident 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
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Cleared under the same submission
K033716 also covers:
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — Howmedica Osteonics Corp.
- Trident — 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 3572e4d9-bcd8-4f42-8657-13531fbb57a5 36 fields · synced Jun 8, 2026