FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
1.1 SCREWDRIVERS
K Number: K872490
·
Decision Jul 23, 1987
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
2
Applicant Total
40
Review Days
30
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Basic Information
- Device Name
- 1.1 SCREWDRIVERS
- K Number
- K872490
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Micro-Aire Surgical Instruments, Inc.
- Date Received
- June 23, 1987
- Decision Date
- July 23, 1987
- Product Code
- LRZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRZ | Screwdriver, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRZ), ordered by most recent decision date.
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STANDARD SCREW DRIVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K902676 | MICROGUARD, ORTHOPEDIC PIN PROTECTORS | 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 |