Identity
- Trade Name
- Equinoxe FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- EQUINOXE PHX TROCAR K-WIRE, 200MM FDA UDI
- Model / Reference
- 371-20-00 FDA UDI
- Description
- EQUINOXE PHX TROCAR K-WIRE, 200MM FDA UDI
Identifiers
- Catalog Number
- 371-20-00 FDA UDI
- Primary DI / UDI-DI
- 10885862591302 FDA UDI
- 510(k) Number
- K223933 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Dimensions & Sizes
- Size
- Length — 200 Millimeter FDA UDI
Category: Fluted surgical drill bit, single-use
Equinoxe by Exactech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223933 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exactech, Inc.
Sources (1)
- FDA UDI 16fa7ab2-0f55-4982-8c38-c54461b71fb0 36 fields · synced Jun 8, 2026