FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUB-TALAR LOK, MODEL 7-11 MM
K Number: K080280
·
Decision Mar 14, 2008
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
10
Review Days
39
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
- SUB-TALAR LOK, MODEL 7-11 MM
- K Number
- K080280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instratek, Inc.
- Date Received
- February 4, 2008
- Decision Date
- March 14, 2008
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWC), ordered by most recent decision date.
VEOFIX Snap Off Screw
FDA 510(k)
FDA Class 2
·Orthopedic
CoLink® & CoLag® Non-Sterile Screws
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed Compression Screws
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Beaming System
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Threaded Trimmable Fixation Nail
FDA 510(k)
FDA Class 2
·Orthopedic
TITAN Nail; APTUS K-Wire System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Instratek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133523 | STAPIX SUPERELASTIC IMPLANT BONE STAPLES | Feb 6, 2014 | Substantially Equivalent |
| K131620 | JONES-FX FRACTURE SYSTEM | Jul 25, 2013 | Substantially Equivalent |
| K120493 | MINI CANNULATED HEADED AND HEADLESS SCREW SET | May 17, 2012 | Substantially Equivalent |
| K111032 | CMC CABLE FIX | Aug 31, 2011 | Substantially Equivalent |
| K091763 | MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 | Aug 14, 2009 | Substantially Equivalent |
| K082384 | HAV-LOK BUNION CORRECTION SYSTEM | Dec 8, 2008 | Substantially Equivalent |
| K940230 | ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS | Dec 12, 1994 | Substantially Equivalent |
| K925083 | ENDOTRAK SYSTEM | Apr 27, 1993 | Substantially Equivalent |
| K922391 | ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS | Aug 18, 1992 | Substantially Equivalent |