FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAKAR MINI CANNULATED CANCELLOUS SCREWS
K Number: K912021
·
Decision Nov 22, 1991
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
28
Review Days
199
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Basic Information
- Device Name
- MAKAR MINI CANNULATED CANCELLOUS SCREWS
- K Number
- K912021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Instrument Makar, Inc.
- Date Received
- May 7, 1991
- Decision Date
- November 22, 1991
- 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 Instrument Makar, Inc.
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|---|---|---|---|
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| K963396 | BIOSPHERE SUTURE ANCHOR | May 6, 1997 | Substantially Equivalent |
| K964364 | DISPOSABLE APRON | Feb 25, 1997 | Substantially Equivalent |
| K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | Nov 19, 1996 | Substantially Equivalent |
| K960555 | BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR | Jul 9, 1996 | Substantially Equivalent |
| K943249 | BIOABSORBABLE INTERFERENCE SCREW | Jul 31, 1995 | Substantially Equivalent |
| K942828 | MAKAR FULL AND HALF FACE SHIELD | Feb 23, 1995 | Substantially Equivalent |
| K944062 | LAPRASCOPIC GRASPER | Feb 23, 1995 | Substantially Equivalent |
| K930980 | INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW | Feb 10, 1994 | Substantially Equivalent for Some Indications |