Identity
- Trade Name
- Acetabular Shell with Ti-Coat, 50mm FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Model / Reference
- 3400.50.000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814703010408 FDA UDI
- 510(k) Number
- K100445 FDA UDI
- FDA Product Code
- LWJ FDA UDIMBL FDA UDILPH FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3358 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
Radiation Sterilization FDA UDI
Category: Acetabular shell
Acetabular Shell with Ti-Coat, 50mm by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100445 also covers:
- 32mm Femoral Head, 12/14 Taper, +0mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 32mm Femoral Head, 12/14 Taper, +3.5mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 32mm Femoral Head, 12/14 Taper, +7mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 32mm Femoral Head, 12/14 Taper, -3.5mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 36mm Femoral Head, 12/14 Taper, +0mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 36mm Femoral Head, 12/14 Taper, +3.5mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 36mm Femoral Head, 12/14 Taper, +7mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- 36mm Femoral Head, 12/14 Taper, -3.5mm Offset — TOTAL JOINT ORTHOPEDICS, INC.
- Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 48mm — TOTAL JOINT ORTHOPEDICS, INC.
- Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 50mm — TOTAL JOINT ORTHOPEDICS, INC.
- Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 52mm — TOTAL JOINT ORTHOPEDICS, INC.
- Acetabular Insert with ApeX-Lnk Poly, 32mm Head, Size 54mm — 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 |
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Manufacturer
- Manufacturer
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA UDI ca0c1e91-4439-48c9-8f12-9f36a12f6f09 36 fields · synced May 30, 2026