FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iNSitu Bipolar Hip System
K Number: K191297
·
Decision Sep 17, 2019
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
4
Review Days
126
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
- iNSitu Bipolar Hip System
- K Number
- K191297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theken Companies, LLC
- Date Received
- May 14, 2019
- Decision Date
- September 17, 2019
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWY), ordered by most recent decision date.
b-ONE® Bipolar Head
FDA 510(k)
FDA Class 2
·Orthopedic
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
FDA 510(k)
FDA Class 2
·Orthopedic
CORAIL Cemented Femoral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
SpaceFlex Acetabular Cup
FDA 510(k)
FDA Class 2
·Orthopedic
Vario-Cup System
FDA 510(k)
FDA Class 2
·Orthopedic
COPAL exchange G hip spacer
FDA 510(k)
FDA Class 2
·Orthopedic