Identity
- Trade Name
- SI-RESTORE FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- THREADED STEINMANN PIN FDA UDI
- Model / Reference
- 1701-300057 FDA UDI
- Description
- THREADED STEINMANN PIN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850073363669 FDA UDI
- 510(k) Number
- K182919 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.2 Millimeter FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Si-Restore by Biofusion Management And Manufacturing, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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Cleared under the same submission
K182919 also covers:
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
- SI-RESTORE — BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
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
- Biofusion Management And Manufacturing, Llc
Sources (1)
- FDA UDI 35e47a6c-0042-4f76-adf9-52c8f6a51aed 35 fields · synced May 30, 2026