Identity
- Trade Name
- Equinoxe FDA UDI
- Generic Name
- Resurfacing humeral head prosthesis FDA UDI
- Model / Reference
- 312-01-53 FDA UDI
Identifiers
- Catalog Number
- 312-01-53 FDA UDI
- Primary DI / UDI-DI
- 10885862248558 FDA UDI
- 510(k) Number
- K131298 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Resurfacing humeral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 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 — 53 Millimeter FDA UDI
Category: Resurfacing humeral head prosthesis
Equinoxe by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Resurfacing humeral head prosthesis.
- AEQUALIS RESURFACING HEAD — TORNIER, INC. · Class II
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc · Class II
- SMR System — Limacorporate · Class II
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc · Class II
- COPELAND EAS SHOULDER SYSTEM — Biomet Orthopedics, Inc. · Class II
- Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc. · Class II
- Titan™ — Ascension Orthopedics, Inc. · Class II
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K131298 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 4dceaf00-0487-428d-82a5-72ba27c88a2e 35 fields · synced May 30, 2026