Identity
- Trade Name
- Equinoxe FDA UDI
- Generic Name
- Surgical instrument handle, torque-limiting FDA UDI
- Device Name
- ANATOMIC COUNTER TORQUE FDA UDI
- Model / Reference
- 301-16-35 FDA UDI
- Description
- ANATOMIC COUNTER TORQUE FDA UDI
Identifiers
- Catalog Number
- 301-16-35 FDA UDI
- Primary DI / UDI-DI
- 10885862557711 FDA UDI
- 510(k) Number
- K063569 FDA UDI
- FDA Product Code
- KWT FDA UDI
- GMDN Term
- Surgical instrument handle, torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3650 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: Surgical instrument handle, torque-limiting
Equinoxe by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument handle, torque-limiting.
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- PERLA ® — Spineart · Class II
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- ReLine — Nuvasive, Inc. · Class I
- InCore MPJ — Medartis Inc. · Class I
- KONG-TL VBR System, Torque Limiter with Coupling, 1/4'' Coupling, 1 Nm — Icotec · Class II
Cleared under the same submission
K063569 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exactech, Inc.
Sources (1)
- FDA UDI 9d215b90-362f-4093-96a0-6d4bba8fb61a 35 fields · synced Jun 8, 2026