FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROGUARD, ORTHOPEDIC PIN PROTECTORS
K Number: K902676
·
Decision Sep 14, 1990
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
8
Applicant Total
40
Review Days
87
Basic Information
- Device Name
- MICROGUARD, ORTHOPEDIC PIN PROTECTORS
- K Number
- K902676
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- MICRO-AIRE SURGICAL INSTRUMENTS, INC.
- Date Received
- June 19, 1990
- Decision Date
- September 14, 1990
- Product Code
- LYT
- 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 |
|---|---|---|---|
| LYT | Fixation Accessory | FDA class 2 | Orthopedic |
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Other Clearances by MICRO-AIRE SURGICAL INSTRUMENTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K904949 | A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS | Nov 26, 1990 | Substantially Equivalent |
| K903713 | OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 | Sep 14, 1990 | Substantially Equivalent |
| K903650 | OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 | Sep 14, 1990 | Substantially Equivalent |
| K903664 | MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL | Sep 13, 1990 | Substantially Equivalent |
| K901967 | DENDIA WERK BURS AND CUTTING DISCS | Jul 13, 1990 | Substantially Equivalent |
| K901735 | ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 | Jun 20, 1990 | Substantially Equivalent |
| K902168 | ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) | Jun 20, 1990 | Substantially Equivalent |
| K900033 | MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS | Feb 13, 1990 | Substantially Equivalent |
| K900210 | BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 | Feb 2, 1990 | Substantially Equivalent |
| K896280 | MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 | Nov 22, 1989 | Substantially Equivalent |