FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIAO HAND SURGERY SET
K Number: K960539
·
Decision Jul 23, 1996
Classifications
1
FEI Numbers
373
Registration Numbers
373
Same Product Code
14
Applicant Total
19
Review Days
167
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
- DIAO HAND SURGERY SET
- K Number
- K960539
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kinetikos Medical, Inc.
- Date Received
- February 7, 1996
- Decision Date
- July 23, 1996
- Product Code
- HXB
- 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 |
|---|---|---|---|
| HXB | Probe | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXB), ordered by most recent decision date.
COHORT AVB RETRACTOR SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
FDA 510(k)
FDA Class 1
·Orthopedic
SURGICAL PROBE
FDA 510(k)
FDA Class 1
·Orthopedic
HOOK PROBE #TM-1376
FDA 510(k)
FDA Class 1
·Orthopedic
BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375
FDA 510(k)
FDA Class 1
·Orthopedic
BOWEN PROBE
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Kinetikos Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061749 | ECLIPSE TOTAL ANKLE IMPLANT | Nov 22, 2006 | Substantially Equivalent |
| K061465 | KMI CEMENT RESTRICTOR IMPLANT | Oct 5, 2006 | Unknown |
| K051611 | MBARESORB IMPLANT | Sep 6, 2005 | Substantially Equivalent |
| K041461 | KMI DISTAL VOLAR RADIUS PLATE SYSTEM | Aug 16, 2004 | Substantially Equivalent |
| K032806 | KATALYST RADIAL HEAD IMPLANT | Apr 16, 2004 | Substantially Equivalent |
| K040356 | KOMPRESSOR SCREW SYSTEM | Mar 1, 2004 | Substantially Equivalent |
| K024233 | KOMPRESSOR SCREW SYSTEM | Feb 6, 2003 | Substantially Equivalent |
| K030037 | UNIVERSAL TOTAL WRIST SYSTEM | Feb 5, 2003 | Substantially Equivalent |
| K023770 | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) | Dec 12, 2002 | Substantially Equivalent |
| K020554 | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | May 3, 2002 | Substantially Equivalent |