Identity
- Trade Name
- Sterile Spine Pedicle Screw System FDA UDI
- Generic Name
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
- Device Name
- Ø5.5 Counter Torque, 90° Handle FDA UDI
- Model / Reference
- 62-2676-20 FDA UDI
- Description
- Ø5.5 Counter Torque, 90° Handle FDA UDI
Identifiers
- Catalog Number
- 62-2676-20 FDA UDI
- Primary DI / UDI-DI
- B562090685NS0 FDA UDI
- FDA Product Code
- HXO FDA UDI
- GMDN Term
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Sterile Spine Pedicle Screw System by Wishbone Medical Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Wishbone Medical Inc.
Sources (1)
- FDA UDI c2470f77-59ee-41db-98a1-b3e2e7c53c0f 35 fields · synced May 30, 2026