Identity
- Trade Name
- Arcos® Revision Hip Instrumentation FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Model / Reference
- 31-301912 FDA UDI
Identifiers
- Catalog Number
- 31-301912 FDA UDI
- Primary DI / UDI-DI
- 05019279431496 FDA UDI
- 510(k) Number
- K100469 FDA UDI
- FDA Product Code
- JDI FDA UDIMEH FDA UDILPH FDA UDIKWZ FDA UDILZO FDA UDIKWY FDA UDIMAY FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3353 FDA UDI888.3358 FDA UDI888.3310 FDA UDI888.3390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Arcos® Revision Hip Instrumentation by Biomet Uk Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
- DJO SURGICAL — DJO, LLC · Class I
- ALEUTIAN Interbody Systems — K2M, INC. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- A/P Sizer, Klassic ONE — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- ARCADIUS XP C — AESCULAP, INC. · Class I
- LUCENT — SPINAL ELEMENTS, INC. · Class I
- U-KneeTec — CORIN LTD · Class II
- NCB® — Zimmer, Inc. · Class II
Cleared under the same submission
K100469 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 MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc.
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc.
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc.
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc.
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc.
- ARCOS MODULAR REVISION 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Uk Ltd
Sources (1)
- FDA UDI 6a22075d-d2f9-4c85-a56b-b4c7cbc78437 35 fields · synced May 29, 2026