Summit Si Oct Spinal Fixation System
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- SUMMIT SI OCT SPINAL FIXATION SYSTEM EUDAMEDSUMMIT FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- Mountaineer Clamp Tap Drill Bender Feeler Torque Template EUDAMEDSUMMIT SI OCT SPINAL FIXATION SYSTEM TEMPLATE,3-HOLE T-PLATE 45mm FDA UDI
- Model / Reference
- MOUNTAINEER OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED274667345 EUDAMEDFDA UDI
- Description
- SUMMIT SI OCT SPINAL FIXATION SYSTEM TEMPLATE,3-HOLE T-PLATE 45mm FDA UDI
Identifiers
- Catalog Number
- 274667345 FDA UDI
- Primary DI / UDI-DI
- 10705034193403 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a001465Z EUDAMED
- Direct Marketing DI
- 10705034193403 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical implant template, reusable
Summit Si Oct Spinal Fixation System by Medos International Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant template, reusable.
- Newclip Instruments — NEWCLIP TECHNICS · Class I
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- LIGAFIX® — S.B.M. SAS · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a001465Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 2cc5d165-5c35-4185-8939-ec9cecc03391 61 fields · synced Jun 18, 2026
- FDA UDI 08994bb4-f89f-4d08-beb6-34c03df82444 35 fields · synced May 29, 2026