FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REVERSE SHOULDER PROSTHESIS
K Number: K092873
·
Decision Oct 27, 2009
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
203
Applicant Total
1
Review Days
39
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
- REVERSE SHOULDER PROSTHESIS
- K Number
- K092873
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Djo Surgical
- Date Received
- September 18, 2009
- Decision Date
- October 27, 2009
- Product Code
- PHX
- 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 |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PHX), ordered by most recent decision date.
Augment Off-Axis Instrument System
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
MSS - Humeral reverse liners extension
FDA 510(k)
FDA Class 2
·Orthopedic
Veritas Reverse Total Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
FDA 510(k)
FDA Class 2
·Orthopedic
Equinoxe® Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic