Identity
- Trade Name
- Proximal Reamer Ø16 FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Model / Reference
- 111-552-426 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215152710 FDA UDI
- 510(k) Number
- K243029 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, flexible FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Medullary canal orthopaedic reamer, flexible
Proximal Reamer Ø16 by Signature Orthopaedics Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medullary canal orthopaedic reamer, flexible.
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- Arthrex® — Arthrex, Inc. · Class I
- NITINOL MODULAR REAMER HUDSON — Biomet Orthopedics, Inc. · Class I
- Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Arthrex® — Arthrex, Inc. · Class I
Cleared under the same submission
K243029 also covers:
- Nebula High Offset Size 0 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 1 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 10 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 11 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 12 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 2 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 3 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 5 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 6 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 7 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 8 — SIGNATURE ORTHOPAEDICS PTY LTD
- Nebula High Offset Size 9 — 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 ae05e398-ed21-4e15-b39a-62f59dba9651 33 fields · synced May 30, 2026