Identity
- Trade Name
- Full XPE cup FDA UDI
- Generic Name
- Polyethylene acetabulum prosthesis FDA UDI
- Device Name
- Full XPE cup, ID 36mm, OD 56mm FDA UDI
- Model / Reference
- 1302-3656 FDA UDI
- Description
- Full XPE cup, ID 36mm, OD 56mm FDA UDI
Identifiers
- Catalog Number
- 1302-3656 FDA UDI
- Primary DI / UDI-DI
- 04711605568838 FDA UDI
- 510(k) Number
- K163441 FDA UDI
- FDA Product Code
- LZO FDA UDIJDI FDA UDI
- GMDN Term
- Polyethylene acetabulum prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3350 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
No
FDA UDI
Category: Polyethylene acetabulum prosthesis
Full XPE cup by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene acetabulum prosthesis.
- ZCA® — Zimmer, Inc. · Class II
- Acetabular Insert — Howmedica Osteonics Corp. · Class II
- Cenator Total Hip System — CORIN LTD · Class II
- Exeter — Howmedica Osteonics Corp. · Class II
- Exeter — Howmedica Osteonics Corp. · Class II
- ZCA® — Zimmer, Inc. · Class II
- REFLECTION — Smith & Nephew, Inc. · Class II
- ZCA® — Zimmer, Inc. · Class II
Cleared under the same submission
K163441 also covers:
- Auto break-off locking nut, M10 — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 20mm — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 25mm — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 30mm — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 35mm — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 40mm — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 45mm — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 55mm — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 60mm — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 65mm — UNITED ORTHOPEDIC CORP.
- Cancellous locking screw, Ø6.5 × 75mm — UNITED ORTHOPEDIC CORP.
- Full XPE cup — UNITED ORTHOPEDIC 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
- United Orthopedic Corp.
Sources (1)
- FDA UDI 1c90f53d-6f28-4882-b00d-6f9741a68562 37 fields · synced Jun 8, 2026