Identity
- Trade Name
- SKYHAWK FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- SKYHAWK PLATE IMPLANTS, SIZE 14 FDA UDI
- Model / Reference
- 24-2014 FDA UDI
- Description
- SKYHAWK PLATE IMPLANTS, SIZE 14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18257200087655 FDA UDI
- 510(k) Number
- K140260 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Spinal fixation plate, non-bioabsorbable
Skyhawk by Orthofix US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
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- ACP — Nuvasive, Inc. · Class II
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Cleared under the same submission
K140260 also covers:
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US LLC
- SKYHAWK — Orthofix US 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
- Orthofix US LLC
Sources (1)
- FDA UDI 3c87f719-eae0-403d-aad5-0554d6d80d8a 35 fields · synced Jun 8, 2026