Identity
- Trade Name
- Equinoxe FDA UDI
- Generic Name
- Partial shoulder prosthesis FDA UDI
- Model / Reference
- 304-01-12 FDA UDI
Identifiers
- Catalog Number
- 304-01-12 FDA UDI
- Primary DI / UDI-DI
- 10885862083265 FDA UDI
- 510(k) Number
- K042021 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDI
- GMDN Term
- Partial shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDI
Category: Partial shoulder prosthesis
Equinoxe by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Partial shoulder prosthesis.
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC. · Class II
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc. · Class II
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc. · Class II
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC. · Class II
- Comprehensive® SRS — Biomet Orthopedics, Inc. · Class II
- GLOBAL CAP — DEPUY ORTHOPAEDICS, INC. · Class II
- Comprehensive® SRS — Biomet Orthopedics, Inc. · Class II
- INTEGRATED SHOULDER SYSTEM — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K042021 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 4849c2a0-23e0-4a18-82e4-1b89a3a22f71 35 fields · synced Jun 8, 2026