Identity
- Trade Name
- SMR FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- SMR : HEMISPHERICAL HUMERAL REAMER Ø50mm FDA UDI
- Model / Reference
- HEMISPHERICAL HUMERAL REAMER FDA UDI
- Description
- SMR : HEMISPHERICAL HUMERAL REAMER Ø50mm FDA UDI
Identifiers
- Catalog Number
- 9CCA.13.012 FDA UDI
- Primary DI / UDI-DI
- 08033390111256 FDA UDI
- 510(k) Number
- K112900 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 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: Bone-resection orthopaedic reamer, reusable
Smr by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112900 also covers:
- SMR — Limacorporate
- SMR — Limacorporate
- SMR — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
- SMR Resurfacing System — Limacorporate
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Limacorporate
Sources (1)
- FDA UDI f5a814a7-2b53-4698-ac69-71b7d4f57720 36 fields · synced May 30, 2026