Identity
- Trade Name
- Axis FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- X-Clip, 7.5 x 30 mm FDA UDI
- Model / Reference
- 130-75930 FDA UDI
- Description
- X-Clip, 7.5 x 30 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842078113721 FDA UDI
- 510(k) Number
- K171018 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Implantable bone washer
Axis by Extremity Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171018 also covers:
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, LLC
- Axis — Extremity Medical, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Extremity Medical, LLC
Sources (1)
- FDA UDI 55536507-8fd2-4e77-b6df-5286c9a37d59 34 fields · synced Jun 9, 2026