Identity
- Trade Name
- RINGLOC HIP SYSTEM FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Model / Reference
- 11-105853 FDA UDI
Identifiers
- Catalog Number
- 11-105853 FDA UDI
- Primary DI / UDI-DI
- 00880304201927 FDA UDI
- FDA Product Code
- JDI FDA UDILPH FDA UDILZO FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3358 FDA UDI888.3353 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: Non-constrained polyethylene acetabular liner
Ringloc Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-constrained polyethylene acetabular liner.
- C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
- PRIME — MicroPort Orthopedics Inc. · Class II
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- Continuum® Trilogy® Allofit® Longevity® — Zimmer, Inc. · Class II
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Cleared under the same submission
K023357 also covers:
- HEXLOC MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- HEXLOC MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
K970501 also covers:
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc.
- RINGLOC 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 f51e62ce-5d9a-4fc3-9ca5-b104f90b4b2b 36 fields · synced May 30, 2026