Identity
- Trade Name
- Sterile Spine Pedicle Screw System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Ø5.5 Polyaxial Pedicle Screw, Non-Cannulated, w/Cap Ø5.5 X 25mm (Blue) FDA UDI
- Model / Reference
- 06.6360B-1-WB FDA UDI
- Description
- Ø5.5 Polyaxial Pedicle Screw, Non-Cannulated, w/Cap Ø5.5 X 25mm (Blue) FDA UDI
Identifiers
- Primary DI / UDI-DI
- B562066360B1WB0 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
- Not 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sterile Spine Pedicle Screw System by Wishbone Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Wishbone Medical Inc.
Sources (1)
- FDA UDI f15650c5-72b4-4f2d-bd36-2a29951f8d98 34 fields · synced Jun 6, 2026