Identity
- Trade Name
- MiniHip Stem FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- Size 7 Minihip Broach Male Spigot Connection FDA UDI
- Model / Reference
- 580.90269999999998 FDA UDI
- Description
- Size 7 Minihip Broach Male Spigot Connection FDA UDI
Identifiers
- Catalog Number
- 580.90269999999998 FDA UDI
- Primary DI / UDI-DI
- 05055343869512 FDA UDI
- 510(k) Number
- K083312 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
MiniHip 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
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- 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
K083312 also covers:
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 721464b9-a29c-456b-b2a1-fe6c703cdf49 36 fields · synced May 30, 2026