Identity
- Trade Name
- Fusion Taper Sleeve +6mm FDA UDI
- Generic Name
- Femoral head/stem prosthesis adaptor FDA UDI
- Model / Reference
- 111-37-0008 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215062163 FDA UDI
- 510(k) Number
- K201047 FDA UDI
- FDA Product Code
- MEH FDA UDILZO FDA UDIMBL FDA UDI
- GMDN Term
- Femoral head/stem prosthesis adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
Yes
FDA UDI
Category: Femoral head/stem prosthesis adaptor
Fusion Taper Sleeve +6mm by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femoral head/stem prosthesis adaptor.
- PROFEMUR® — MicroPort Orthopedics Inc. · Class II
- Biolox — Howmedica Osteonics Corp. · Class II
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Solitude Unipolar — ORTHO DEVELOPMENT CORP. · Class II
- CONSERVE® — MicroPort Orthopedics Inc. · Class II
- PROFEMUR® — MicroPort Orthopedics Inc. · Class II
- BIO-MOORE ENDO II HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K201047 also covers:
- 28mm Fusion Trial Head — SIGNATURE ORTHOPAEDICS PTY LTD
- 32mm Fusion Trial Head — SIGNATURE ORTHOPAEDICS PTY LTD
- 36mm Fusion Trial Head — SIGNATURE ORTHOPAEDICS PTY LTD
- Fusion Ceramic Head 28mm — SIGNATURE ORTHOPAEDICS PTY LTD
- Fusion Ceramic Head 32mm — SIGNATURE ORTHOPAEDICS PTY LTD
- Fusion Ceramic Head 36mm — SIGNATURE ORTHOPAEDICS PTY LTD
- Fusion Taper Sleeve +2mm — SIGNATURE ORTHOPAEDICS PTY LTD
- Fusion Taper Sleeve +4mm — SIGNATURE ORTHOPAEDICS PTY LTD
- Fusion Taper Sleeve +8mm — SIGNATURE ORTHOPAEDICS PTY LTD
- Fusion Taper Sleeve -2mm — SIGNATURE ORTHOPAEDICS PTY LTD
- Fusion Taper Sleeve -4mm — SIGNATURE ORTHOPAEDICS PTY LTD
- Fusion Taper Sleeve 0mm — SIGNATURE ORTHOPAEDICS PTY LTD
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
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI e49612a4-385d-41aa-aceb-a58d74410ee7 33 fields · synced May 30, 2026