FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMALL FRAGMENT PLATES AND SCREWS
K Number: K951302
·
Decision May 5, 1995
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
52
Applicant Total
3
Review Days
44
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
- SMALL FRAGMENT PLATES AND SCREWS
- K Number
- K951302
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medpac
- Date Received
- March 22, 1995
- Decision Date
- May 5, 1995
- Product Code
- JDS
- 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 |
|---|---|---|---|
| JDS | Nail, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDS), ordered by most recent decision date.
TRIGEN Stable Lock Nut & Washer
FDA 510(k)
FDA Class 2
·Orthopedic
TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
TRIGEN INTERTAN 10S Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
NET BRAND Osteosynthesis Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
TRIGEN META-NAIL Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
FDA 510(k)
FDA Class 2
·Orthopedic