Identity
- Trade Name
- Metafix Hip Stem FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- Size 10 Femoral Broach FDA UDI
- Model / Reference
- 340.440H FDA UDI
- Description
- Size 10 Femoral Broach FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055343891667 FDA UDI
- 510(k) Number
- K153381 FDA UDI
- FDA Product Code
- MEH FDA UDIOQI FDA UDIJDI FDA UDIKWY FDA UDIKWL FDA UDILZO FDA UDI
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3350 FDA UDI888.3390 FDA UDI888.3360 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: Orthopaedic broach
Metafix Hip Stem by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic broach.
- EcoFit® broach for short stem 133° — implantcast GmbH · Class I
- PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- Equinoxe — Exactech, Inc. · Class II
- Anthology — Smith & Nephew, Inc. · Class I
- Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- iNSitu™ Hip System — Nextstep Arthropedix · Class I
- TEMA Elbow — Limacorporate · Class II
Cleared under the same submission
K153381 also covers:
- Metafix HIp Stem — CORIN LTD
- Metafix HIp Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
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
- Corin Ltd
Sources (1)
- FDA UDI 66e52c00-5bdb-4fac-9895-dade978f5b99 34 fields · synced May 30, 2026