FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
TENET TIBIAL FRACTURE SUPPORT
K Number: K964102
·
Decision Dec 5, 1996
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
7
Applicant Total
3
Review Days
55
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
- TENET TIBIAL FRACTURE SUPPORT
- K Number
- K964102
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tenet Medical Engineering
- Date Received
- October 11, 1996
- Decision Date
- December 5, 1996
- Product Code
- GBB
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBB | Chair, Surgical, Ac-Powered | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBB), ordered by most recent decision date.
HYDRAULIC FOOT OPERATED STOOL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NUTROMAT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LITHOTOMY CHAIR #415
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAGASHIMA SN OPERATOR'S CHAIR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EXAMINATION & TREATMENT CHAIRS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAGASHIMA SN AUTOMATIC TREATMENT CHAIR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery