FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
K Number: K033351
·
Decision Mar 11, 2004
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
90
Applicant Total
3
Review Days
143
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
- GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
- K Number
- K033351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3530
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Global Orthopaedic Technology, USA, Inc.
- Date Received
- October 20, 2003
- Decision Date
- March 11, 2004
- Product Code
- HRY
- 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 |
|---|---|---|---|
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRY), ordered by most recent decision date.
SIGMA High Performance (HP) Partial Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
NanoOrtho NanoKnee® System
FDA 510(k)
FDA Class 2
·Orthopedic
MPO Total Knee Systems MR Labeling
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORIS POROUS PARTIAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
FDA 510(k)
FDA Class 2
·Orthopedic
UNIVATION
FDA 510(k)
FDA Class 2
·Orthopedic