Identity
- Trade Name
- INGENIX FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Polyax Deformity Screw Kit 7.5x65mm for 5.5mm Rod FDA UDI
- Model / Reference
- 55057565 FDA UDI
- Description
- Polyax Deformity Screw Kit 7.5x65mm for 5.5mm Rod FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843672101855 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Spinal bone screw, non-bioabsorbable
Ingenix by Ingenium Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
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
- Ingenium Spine
Sources (1)
- FDA UDI bb8c9165-ad98-4ab9-8f3f-299d239a6c06 33 fields · synced Jun 1, 2026