Identity
- Trade Name
- CEMENTED CUPS FDA UDI
- Generic Name
- Polyethylene acetabulum prosthesis FDA UDI
- Device Name
- Cemented protruded acet. Cups 20°(UHMWPE) Dia. 54 for head dia. 28 mm FDA UDI
- Model / Reference
- Protruded Cup FDA UDI
- Description
- Cemented protruded acet. Cups 20°(UHMWPE) Dia. 54 for head dia. 28 mm FDA UDI
Identifiers
- Catalog Number
- 5620.50.050 FDA UDI
- Primary DI / UDI-DI
- 08033390013017 FDA UDI
- 510(k) Number
- K112158 FDA UDI
- FDA Product Code
- LPH FDA UDIJDI FDA UDIKWY FDA UDIKWZ FDA UDI
- GMDN Term
- Polyethylene acetabulum prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3350 FDA UDI888.3390 FDA UDI888.3310 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyethylene acetabulum prosthesis
Cemented Cups by Limacorporate — 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
K112158 also covers:
- Acetabular Instrument Set — Limacorporate
- Acetabular Instrument Set — Limacorporate
- Bipolar Head — Limacorporate
- Bipolar Head — Limacorporate
- Bipolar Head — Limacorporate
- Bipolar Head — Limacorporate
- Bipolar Head — Limacorporate
- Bipolar Head — Limacorporate
- Bipolar Head — Limacorporate
- Bipolar Head — Limacorporate
- CEMENTED CUPS — Limacorporate
- CEMENTED CUPS — Limacorporate
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
- Limacorporate
Sources (1)
- FDA UDI 487bcce7-1a20-456e-96f3-7ab983aedcf5 36 fields · synced May 30, 2026