FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
K Number: K926579
·
Decision Apr 6, 1993
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
31
Review Days
133
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Basic Information
- Device Name
- TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
- K Number
- K926579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Techmedica, Inc.
- Date Received
- November 24, 1992
- Decision Date
- April 6, 1993
- 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 |
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Other Clearances by Techmedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933935 | CKS POROUS COATED FEMORAL COMPONENT | Oct 11, 1994 | Substantially Equivalent |
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| 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 |
| 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 |
| K921458 | TMP MICROPLATING SYSTEM | Jul 17, 1992 | Substantially Equivalent |