FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOFLEX ROD
K Number: K102601
·
Decision Jan 14, 2011
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
20
Applicant Total
4
Review Days
127
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
- ORTHOFLEX ROD
- K Number
- K102601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3720
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho-Pro, LLC
- Date Received
- September 9, 2010
- Decision Date
- January 14, 2011
- Product Code
- KWH
- 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 |
|---|---|---|---|
| KWH | Prosthesis, Toe, Constrained, Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWH), ordered by most recent decision date.
NewPrim System
FDA 510(k)
FDA Class 2
·Orthopedic
Fusion Silastic System
FDA 510(k)
FDA Class 2
·Orthopedic
RTS Lesser MTP Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
RTS Flexible 1 MPJ Implant w/Grommets
FDA 510(k)
FDA Class 2
·Orthopedic
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic