Identity
- Trade Name
- Mallet FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Mallet FDA UDI
- Model / Reference
- 317-0016 FDA UDI
- Description
- Mallet FDA UDI
Identifiers
- Catalog Number
- 317-0016 FDA UDI
- Primary DI / UDI-DI
- 00816950029479 FDA UDI
- 510(k) Number
- K210247 FDA UDI
- FDA Product Code
- HXL FDA UDI
- GMDN Term
- Surgical mallet 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
Yes
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 mallet
Mallet by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210247 also covers:
- 13.0mm Tap Cannulated — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 100mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 105mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 110mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 75mm — OsteoCentric Technologies,Inc
- 13mm Integrated Hip Fastener 90mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 100mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 105mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 75mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 80mm — OsteoCentric Technologies,Inc
- 15mm Integrated Hip Fastener 90mm — OsteoCentric Technologies,Inc
- 2.0 x 130mm Drill Bit Calibrated — OsteoCentric Technologies,Inc
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
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 24f85cd7-d508-4623-aac4-f6e2e2b1e7f9 36 fields · synced Jun 8, 2026