Identity
- Trade Name
- 32mm Fusion Trial Head FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Model / Reference
- 112-32-0240 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215082161 FDA UDI
- 510(k) Number
- K201047 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant template, reusable
32mm Fusion Trial Head by Signature Orthopaedics Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201047 also covers:
- 28mm 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 +6mm — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI faf5d02f-0e82-4c88-b66e-7a7c48dbf1a1 33 fields · synced Jun 1, 2026