← Back to catalogue
Cancellous Bone Screw with 6.5mm Head Diameter, 25mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Cancellous Bone Screw with 6.5mm Head Diameter, 25mm FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Model / Reference
- 3600.25.065 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814703010545 FDA UDI
- 510(k) Number
- K100445 FDA UDI
- FDA Product Code
- MBL FDA UDILWJ FDA UDILPH FDA UDI
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3360 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: Metal-on-polyethylene total hip prosthesis
Cancellous Bone Screw with 6.5mm Head Diameter, 25mm by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-on-polyethylene total hip prosthesis.
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- U2 Femoral head, Ø36mm, +0mm — UNITED ORTHOPEDIC CORP. · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- "UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP. · Class II
- Conformis Hip System — Conformis, Inc. · Class II
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP. · Class II
- Initia Total Hip System — Kyocera Corporation · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA UDI 21d735b8-ff7b-4b80-86b4-abf8e6a0e80a 36 fields · synced May 30, 2026