Identity
- Trade Name
- Zavation Deformity Polyaxial Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Fenestrated Standard Threaded Screw 5.5 x 100 FDA UDI
- Model / Reference
- 1011-S-55100-F FDA UDI
- Description
- Fenestrated Standard Threaded Screw 5.5 x 100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00197157045579 FDA UDI
- 510(k) Number
- K222614 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- Not 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
Zavation Deformity Polyaxial Screw by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Zavation
Sources (1)
- FDA UDI 2b6d4158-8a3f-4359-882c-6b6329ce7a14 36 fields · synced May 31, 2026