Identity
- Trade Name
- SynFrame FDA UDI
- Generic Name
- Surgical retraction system mounting frame, reusable FDA UDI
- Device Name
- SYNFRAME LENGTHENER FDA UDI
- Model / Reference
- 387.338 FDA UDI
- Description
- SYNFRAME LENGTHENER FDA UDI
Identifiers
- Catalog Number
- 387338 FDA UDI
- Primary DI / UDI-DI
- 10705034771076 FDA UDI
- 510(k) Number
- K993314 FDA UDI
- FDA Product Code
- FQP FDA UDI
- GMDN Term
- Surgical retraction system mounting frame, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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: Surgical retraction system mounting frame, reusable
SynFrame by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system mounting frame, reusable.
- Blade acc. Caspar lateral 55mm width 23mm PEEK — Geister Medizin Technik GmbH · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- gSource — GSOURCE, LLC. · Class I
- Retractor, Spinal, blade, acc. Honolulu toothed 15x40mm — Geister Medizin Technik GmbH · Class II
- Hayden Medical — Hayden Medical Inc · Class I
- Retractor, Spinal, ring-handle, Längs with hinge with catch — Geister Medizin Technik GmbH · Class II
- Retractor, Spinal, quick-connect Blade medial/lateral 19x60mm prongs — Geister Medizin Technik GmbH · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Cleared under the same submission
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
- Synthes
Sources (1)
- FDA UDI d0d4b4b8-6b26-484b-914c-48fb4c248893 36 fields · synced May 30, 2026