Identity
- Trade Name
- INSTRUMENT FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Device Name
- RESTORATION MODULAR INST SYS CONICAL DISTAL REAMER FDA UDI
- Model / Reference
- 6278-8-318 FDA UDI
- Description
- RESTORATION MODULAR INST SYS CONICAL DISTAL REAMER FDA UDI
Identifiers
- Catalog Number
- 6278-8-318 FDA UDI
- Primary DI / UDI-DI
- 07613327511949 FDA UDI
- FDA Product Code
- MBL FDA UDILZO FDA UDIMEH FDA UDIJDI FDA UDIKWZ FDA UDIMAY FDA UDILPH FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, rigid FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI888.3350 FDA UDI888.3310 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: Medullary canal orthopaedic reamer, rigid
Instrument by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medullary canal orthopaedic reamer, rigid.
- POLARSTEM — Smith & Nephew, Inc. · Class II
- Intramedullary Reamer, Revision — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Comprehensive® Shoulder Instruments — Biomet Orthopedics, Inc. · Class II
- MP Reconstruction System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
- Panta® 2 — Ascension Orthopedics, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- REVISION Hip — Limacorporate · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI 51006a13-6961-48aa-95c2-005da9444e9e 35 fields · synced May 31, 2026