FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOABSORBABLE INTERFERENCE SCREW
K Number: K943249
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
28
Review Days
390
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Basic Information
- Device Name
- BIOABSORBABLE INTERFERENCE SCREW
- K Number
- K943249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrument Makar, Inc.
- Date Received
- July 6, 1994
- Decision Date
- July 31, 1995
- Product Code
- MAI
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Instrument Makar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002600 | LITWIN CRUICATE ANCHOR | Nov 15, 2000 | Substantially Equivalent |
| K980999 | ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT | Nov 6, 1998 | Substantially Equivalent |
| 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 |
| 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 |
| K923841 | BONE SCREWS | Oct 27, 1993 | Substantially Equivalent |