Identity
- Trade Name
- ZAVATION FDA UDI
- Generic Name
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
- Device Name
- Custom Anti-Torque Posterior Cervical FDA UDI
- Model / Reference
- ZAV-1135 FDA UDI
- Description
- Custom Anti-Torque Posterior Cervical FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- 00842166183025 FDA UDI
- FDA Product Code
- KWP FDA UDINKG FDA UDI
- GMDN Term
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Category: Orthopaedic counter-torque/rod-pushing instrument
Zavation by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic counter-torque/rod-pushing instrument.
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- Mariner — SeaSpine Orthopedics Corporation · Class I
- General Instrument — ORTHOPEDIATRICS CORP. · Class I
- Malibu — SeaSpine Orthopedics Corporation · Class I
- Matrix — Synthes · Class I
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 ea897b16-cd02-4712-a57a-5e32d5325988 35 fields · synced May 31, 2026