FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM
K Number: K872156
·
Decision Jul 21, 1987
Classifications
1
FEI Numbers
653
Registration Numbers
653
Same Product Code
1040
Applicant Total
83
Review Days
47
Basic Information
- Device Name
- CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM
- K Number
- K872156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- CONCEPT, INC.
- Date Received
- June 4, 1987
- Decision Date
- July 21, 1987
- 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 CONCEPT, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE | May 1, 1992 | Substantially Equivalent |
| K912957 | CONCEPT MICROMILL | Oct 4, 1991 | Substantially Equivalent |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Jun 5, 1990 | Substantially Equivalent for Some Indications |
| K894929 | STAPLE FIXATION SYSTEM | Aug 30, 1989 | Substantially Equivalent |
| K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) | Aug 1, 1989 | Substantially Equivalent |
| K891109 | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE | May 8, 1989 | Substantially Equivalent |
| K881954 | CONCEPT POWER SYSTEM | Nov 9, 1988 | Substantially Equivalent |
| K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM | Nov 8, 1988 | Substantially Equivalent |
| K882121 | C-FLO SUCTION TUBE | Jun 20, 1988 | Substantially Equivalent |
| K880414 | TENDON HARVESTER | Mar 25, 1988 | Substantially Equivalent |