FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
K Number: K903664
·
Decision Sep 13, 1990
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
64
Applicant Total
40
Review Days
30
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Basic Information
- Device Name
- MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
- K Number
- K903664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Micro-Aire Surgical Instruments, Inc.
- Date Received
- August 14, 1990
- Decision Date
- September 13, 1990
- Product Code
- HBE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBE), ordered by most recent decision date.
Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
FDA 510(k)
FDA Class 2
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Hubly Drill (H100)
FDA 510(k)
FDA Class 2
·Neurology
GREEN
FDA 510(k)
FDA Class 2
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UniBur
FDA 510(k)
FDA Class 2
·Neurology
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)
FDA 510(k)
FDA Class 2
·Neurology
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
FDA 510(k)
FDA Class 2
·Neurology
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 |
| 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 |