← Back to catalogue
Klassic HD Acetabular Insert with XLPE, 36mm head, size 60mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Klassic HD Acetabular Insert with XLPE, 36mm head, size 60mm FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Model / Reference
- 3503.60.036 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814703012891 FDA UDI
- 510(k) Number
- K161073 FDA UDI
- FDA Product Code
- LPH FDA UDIMBL FDA UDILZO FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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
Ethylene Oxide FDA UDI
Category: Non-constrained polyethylene acetabular liner
Klassic HD Acetabular Insert with XLPE, 36mm head, size 60mm by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Non-constrained polyethylene acetabular liner.
- C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
- PRIME — MicroPort Orthopedics Inc. · Class II
- G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
Cleared under the same submission
K161073 also covers:
- Klassic HD Acetabular Insert with XLPE, 32mm head, size 48mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 32mm head, size 50mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 32mm head, size 52mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 32mm head, size 54mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 32mm head, size 56mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 32mm head, size 58mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 32mm head, size 60mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 32mm head, size 62mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 32mm head, size 64mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 36mm head, size 52mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 36mm head, size 54mm — TOTAL JOINT ORTHOPEDICS, INC.
- Klassic HD Acetabular Insert with XLPE, 36mm head, size 56mm — TOTAL JOINT 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
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA UDI d905a827-1258-4ba6-bb1d-b6698f56cb2e 36 fields · synced May 31, 2026