Identity
- Trade Name
- Knee arthroscopy support FDA UDI
- Generic Name
- External orthopaedic fixation system, reusable FDA UDI
- Device Name
- Arthroscopy support EUDAMED
- Model / Reference
- 10-353-10 EUDAMED10-353-US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350111833169 EUDAMED07350111831462 FDA UDI
- Basic UDI-DI
- 735011183ARTHR5S EUDAMED
- Direct Marketing DI
- 07350111833169 EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- P09120499 EXTERNAL BONE FIXATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- External orthopaedic fixation system, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Category: External orthopaedic fixation system, reusable
Knee arthroscopy support by Reison Medical AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, reusable.
- HOFFMANN — Stryker Corp. · Class II
- ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- Integra® External Fixation System — Ascension Orthopedics, Inc. · Class II
- PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- TransFx™ — Zimmer, Inc. · Class I
- HOFFMANN — Stryker Corp. · Class II
- SIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Reison Medical AB
Sources (2)
- FDA UDI 49bea80a-5ba1-4b30-9533-85c34eeedbb0 32 fields · synced Jul 23, 2026
- EUDAMED 3c20dafd-140f-44fa-8eb2-804d5d05ead4 61 fields · synced Jul 23, 2026