Identity
- Trade Name
- IM Tibial Align Block Adaptor FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Model / Reference
- 122-16-0352 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215046231 FDA UDI
- 510(k) Number
- K181338 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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: Orthopaedic implant-instrument extension adaptor, reusable
IM Tibial Align Block Adaptor by Signature Orthopaedics Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant-instrument extension adaptor, reusable.
- Truliant CC — Exactech, Inc. · Class II
- Adaptor Delta Cups — Limacorporate · Class II
- Jet-X — Smith & Nephew, Inc. · Class II
- Comprehensive® Instruments — Biomet Orthopedics, Inc. · Class II
- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
- ACS® — implantcast GmbH · Class I
- Shukla Copter S9COPTER — Shukla Medical · Class I
- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
Cleared under the same submission
K181338 also covers:
- Adjustable Rotator Setter — SIGNATURE ORTHOPAEDICS PTY LTD
- Distal Cut Adaptor — SIGNATURE ORTHOPAEDICS PTY LTD
- Femoral Entry Drill — SIGNATURE ORTHOPAEDICS PTY LTD
- IM Rod — SIGNATURE ORTHOPAEDICS PTY LTD
- IM Tibial Align Connector — SIGNATURE ORTHOPAEDICS PTY LTD
- Instrument Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Ligament Balancing Block — SIGNATURE ORTHOPAEDICS PTY LTD
- Outigger Pin Guide — SIGNATURE ORTHOPAEDICS PTY LTD
- Outrigger Pin — SIGNATURE ORTHOPAEDICS PTY LTD
- Rotation Shim 3º — SIGNATURE ORTHOPAEDICS PTY LTD
- Rotation Shim 5º — SIGNATURE ORTHOPAEDICS PTY LTD
- Rotation Shim 7º — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI 88671b4c-e6c7-421a-92f9-cd792d12c670 33 fields · synced May 30, 2026