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Hoffmann
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 4934-5-100Model 08858251002854TH
Identity
- Trade Name
- Hoffmann LRF™ EUDAMEDHOFFMANN FDA UDI
- Generic Name
- External orthopaedic fixation system, reusable FDA UDI
- Device Name
- HLRF - RING - CLASS I - NON STERILE EUDAMEDFoot Ring Short LRF FDA UDI
- Model / Reference
- 4934-5-100 EUDAMEDFDA UDI08858251002854TH EUDAMED
- Description
- Foot Ring Short LRF FDA UDI
Identifiers
- Catalog Number
- 4934-5-100 FDA UDI
- Primary DI / UDI-DI
- 07613252611394 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251002854TH EUDAMED
- FDA Product Code
- KTT 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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: External orthopaedic fixation system, reusable
Hoffmann by Stryker Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, reusable.
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- Integra® External Fixation System — Ascension Orthopedics, Inc. · Class II
- PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- TransFx™ — Zimmer, Inc. · Class I
- SIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- SIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- SHEFFIELD RING FIXATOR — Orthofix, 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (2)
- FDA UDI 15d63b7c-29a8-4f93-b88a-20dc5d0f34bd 35 fields · synced Aug 1, 2026
- EUDAMED 990e2994-ed75-4d31-af7f-dc45e31a761f 61 fields · synced Aug 1, 2026