Identity
- Trade Name
- AcuMatch FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- BROACH, MODIFIED FIT, SIZE 0 FDA UDI
- Model / Reference
- 113-01-10 FDA UDI
- Description
- BROACH, MODIFIED FIT, SIZE 0 FDA UDI
Identifiers
- Catalog Number
- 113-01-10 FDA UDI
- Primary DI / UDI-DI
- 10885862016775 FDA UDI
- FDA Product Code
- MEH FDA UDIJDI FDA UDILWJ FDA UDILZO FDA UDILPH FDA UDI
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3350 FDA UDI888.3360 FDA UDI888.3358 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
AcuMatch by Exactech, Inc. — 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
- 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
- APEX Knee System — OMNIlife science, Inc. · Class I
Cleared under the same submission
K041906 also covers:
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- Acumatch A Series — Exactech, Inc.
- Acumatch A Series — Exactech, Inc.
- Acumatch A Series — Exactech, Inc.
- Acumatch P Series — Exactech, Inc.
- Exactech — Exactech, Inc.
K051335 also covers:
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
K052787 also covers:
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- AcuMatch — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
- Novation — Exactech, Inc.
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
- Exactech, Inc.
Sources (1)
- FDA UDI cbcb0984-50b6-4738-ba74-e92028639630 36 fields · synced May 29, 2026