Identity
- Trade Name
- ARCOS MODULAR REVISION HIP SYSTEM FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Model / Reference
- 11-302131 FDA UDI
Identifiers
- Catalog Number
- 11-302131 FDA UDI
- Primary DI / UDI-DI
- 00880304493988 FDA UDI
- 510(k) Number
- K090757 FDA UDI
- FDA Product Code
- LZO FDA UDIKWY FDA UDIKWZ FDA UDILPH FDA UDIMAY FDA UDIJDI FDA UDIMEH FDA UDI
- GMDN Term
- Uncoated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3390 FDA UDI888.3310 FDA UDI888.3358 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: Uncoated hip femur prosthesis, modular
Arcos Modular Revision Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated hip femur prosthesis, modular.
- Accolade — Howmedica Osteonics Corp. · Class II
- SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class III
- Corin Taper-Fit Total Hip System — CORIN LTD · Class II
- TaperFit Cemented Hip System — CORIN LTD · Class II
- Omnifit — Howmedica Osteonics Corp. · Class II
- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
Cleared under the same submission
K090757 also covers:
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS — Biomet Orthopedics, Inc.
- ARCOS MODULAR REVISION HIP SYSTEM — Biomet Orthopedics, Inc.
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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI affaa3f4-f687-49fc-9ff7-06779b420b71 36 fields · synced May 30, 2026