Identity
- Trade Name
- Equinoxe FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Device Name
- ERGO MOD BROACH COLLAR FDA UDI
- Model / Reference
- 301-05-00 FDA UDI
- Description
- ERGO MOD BROACH COLLAR FDA UDI
Identifiers
- Catalog Number
- 301-05-00 FDA UDI
- Primary DI / UDI-DI
- 10885862530462 FDA UDI
- 510(k) Number
- K061454 FDA UDI
- FDA Product Code
- HSD FDA UDIKWS FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3660 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 implant-instrument extension adaptor, reusable
Equinoxe by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant-instrument extension adaptor, reusable.
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- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
- ACS® — implantcast GmbH · Class I
- Shukla Copter S9COPTER — Shukla Medical · Class I
- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
- PB Uni tibial impaction adapter — implantcast GmbH · Class I
Cleared under the same submission
K061454 also covers:
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — Exactech, Inc.
- Equinoxe — 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 |
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Manufacturer
- Manufacturer
- Exactech, Inc.
Sources (1)
- FDA UDI 47eebace-e301-4163-8bca-01a9298c6f68 35 fields · synced Jun 6, 2026