Identity
- Trade Name
- SYNFIX Evolution FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/10° FDA UDI
- Model / Reference
- 03.835.343 FDA UDI
- Description
- SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/10° FDA UDI
Identifiers
- Catalog Number
- 03835343 FDA UDI
- Primary DI / UDI-DI
- 10705034816807 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Yes
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: Spinal implant trial
The SYNFIX Evolution Trial Spacer is a reusable spinal implant designed to validate the proper size of the permanent implant required for orthopedic patients. This device features a large deep/13.5mm height and an adjustable angle of 10°, making it suitable for various medical specialties.
Similar devices
Also classified as Spinal implant trial.
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- IdentiTi — ALPHATEC SPINE, INC. · Class II
- MLX — Nuvasive, Inc. · Class I
- IdentiTi — ALPHATEC SPINE, INC. · Class II
- ROI-A — Ldr Spine USA · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Synthes
Sources (1)
- FDA UDI 51785ad7-86f0-482d-87d6-6317af291234 35 fields · synced Jul 17, 2026