Identity
- Trade Name
- EAGLE SWIFT FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- EAGLE/SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-TAPPING 4.4 x 10mm FDA UDI
- Model / Reference
- 183651010 FDA UDI
- Description
- EAGLE/SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-TAPPING 4.4 x 10mm FDA UDI
Identifiers
- Catalog Number
- 183651010 FDA UDI
- Primary DI / UDI-DI
- 10705034095820 FDA UDI
- 510(k) Number
- K070994 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- Not 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
Eagle Swift by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K070994 also covers:
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
- Medos International Sàrl
Sources (1)
- FDA UDI e986f305-07d1-42ba-b6b2-003e02116263 37 fields · synced Jun 1, 2026