Identity
- Trade Name
- Ga-mma Nail FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 52mm, Titanium FDA UDI
- Model / Reference
- TI-600-052 FDA UDI
- Description
- Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 52mm, Titanium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08903993367841 FDA UDI
- 510(k) Number
- K192003 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Ga-mma Nail by Auxein Medical Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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Cleared under the same submission
K192003 also covers:
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- AJAX Nail — Auxein Medical Private Limited
- AJAX Nail — Auxein Medical Private Limited
- AJAX Nail — Auxein Medical Private Limited
- AJAX Nail — Auxein Medical Private Limited
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 |
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Manufacturer
- Manufacturer
- Auxein Medical Private Limited
Sources (1)
- FDA UDI 08981190-8bb3-4394-960f-0e7d17a756c3 35 fields · synced May 31, 2026