FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
K Number: K093430
·
Decision Sep 2, 2010
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
186
Review Days
303
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
- K Number
- K093430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- November 3, 2009
- Decision Date
- September 2, 2010
- Product Code
- KWS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWS), ordered by most recent decision date.
AETOS Shoulder System - CONCELOC Glenoids
FDA 510(k)
FDA Class 2
·Orthopedic
Catalyst F1x Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
AETOS Shoulder System Meta Humeral Prosthesis Size 0
FDA 510(k)
FDA Class 2
·Orthopedic
MyShoulder Planner (5.3SSWPL)
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Humeral Reconstruction System (Tornier HRS)
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Exactech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260583 | Equinoxe® Shoulder System | Apr 14, 2026 | Substantially Equivalent |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Dec 1, 2025 | Substantially Equivalent |
| K243448 | Equinoxe® Shoulder System | Aug 1, 2025 | Substantially Equivalent |
| K243275 | Equinoxe® Scapula Fracture System | Jun 26, 2025 | Substantially Equivalent |
| K243839 | Alteon® HA Femoral Stems | Mar 10, 2025 | Substantially Equivalent |
| K240393 | Exactech® TRULIANT® Knee System | Oct 3, 2024 | Substantially Equivalent |
| K233482 | Equinoxe® Central Screw Baseplate System | Jul 18, 2024 | Substantially Equivalent |
| K230717 | Exactech® Vantage® Total Ankle System | Oct 12, 2023 | Substantially Equivalent |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Sep 25, 2023 | Substantially Equivalent |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Sep 14, 2023 | Substantially Equivalent |