← Back to catalogue
Orthopedic Manual Surgical Instrument
FDA UDIClass I (US FDA UDI)
by Wiltrom Inc.
Identity
- Trade Name
- Orthopedic Manual Surgical Instrument FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic procedures to assist implantation of Wiltrom implants. The Wiltrom Orthopedic Surgical Instruments are provided non-sterile and must be sterilized prior to use. FDA UDI
- Model / Reference
- 70091 Pin M1.4*L500mm FDA UDI
- Description
- Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic procedures to assist implantation of Wiltrom implants. The Wiltrom Orthopedic Surgical Instruments are provided non-sterile and must be sterilized prior to use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719875729782 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Orthopedic Manual Surgical Instrument by Wiltrom Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
- DJO SURGICAL — DJO, LLC · Class I
- ALEUTIAN Interbody Systems — K2M, INC. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- A/P Sizer, Klassic ONE — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- ARCADIUS XP C — AESCULAP, INC. · Class I
- LUCENT — SPINAL ELEMENTS, INC. · Class I
- U-KneeTec — CORIN LTD · Class II
- NCB® — Zimmer, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wiltrom Inc.
Sources (1)
- FDA UDI 138d9912-2238-48bf-b9f7-abbf432dd8fa 35 fields · synced Jun 8, 2026