FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSTEOTOMY BONE STAPLE
K Number: K830255
·
Decision Mar 9, 1983
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
5
Applicant Total
31
Review Days
43
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
- OSTEOTOMY BONE STAPLE
- K Number
- K830255
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Techmedica, Inc.
- Date Received
- January 25, 1983
- Decision Date
- March 9, 1983
- Product Code
- HXJ
- 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 |
|---|---|---|---|
| HXJ | Staple Driver | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXJ), ordered by most recent decision date.
IN-TAC BONE ANCHOR SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
UROTAC BONE ANCHOR INSERTER
FDA 510(k)
FDA Class 1
·Orthopedic
ELECTRIC WIRE DRIVER, MODEL 2640E
FDA 510(k)
FDA Class 1
·Orthopedic
FIXATION STAPLE KIT - DLIDE HAMMER
FDA 510(k)
FDA Class 1
·Orthopedic
STAPLE INSERTER-EXTRACTOR FOR ARTHROS
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Techmedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933935 | CKS POROUS COATED FEMORAL COMPONENT | Oct 11, 1994 | Substantially Equivalent |
| K932017 | TECHMEDICA CONTINUUM HIP WITH HA COATING | Sep 1, 1994 | Substantially Equivalent |
| K931929 | TECHMEDICA CONTINUUM HIP SYSTEM | Mar 29, 1994 | Substantially Equivalent |
| K926387 | TECHMEDICA STANDARD CEMENTED HIP SYSTEM | Feb 1, 1994 | Substantially Equivalent |
| K925420 | TECHMEDICA STANDARD BIPOLAR SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K923808 | MULLER STRAIGHT STEM FEMORAL PROSTHESIS | Jul 27, 1993 | Substantially Equivalent |
| K926579 | TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE | Apr 6, 1993 | Substantially Equivalent |
| K911058 | TECHMEDICA CAD/CAM CUSTOM HIP | Feb 23, 1993 | Substantially Equivalent |
| K925181 | TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP | Feb 5, 1993 | Substantially Equivalent |
| K920080 | CONTINUUM KNEE SYSTEM | Sep 1, 1992 | Substantially Equivalent for Some Indications |