FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAYLOR(TM) DRILL STOP
K Number: K873692
·
Decision Dec 17, 1987
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
64
Applicant Total
17
Review Days
100
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Basic Information
- Device Name
- RAYLOR(TM) DRILL STOP
- K Number
- K873692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Cedar Surgical, Inc.
- Date Received
- September 8, 1987
- Decision Date
- December 17, 1987
- 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
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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)
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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
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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)
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Other Clearances by Cedar Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872281 | RAYLOR FUSION FUNNEL | Nov 2, 1987 | Substantially Equivalent |
| K873690 | CEDAR(TM) PELVIC CUSHION | Oct 26, 1987 | Substantially Equivalent |
| K873691 | CEDAR(TM) RETRACTOR RING | Sep 28, 1987 | Substantially Equivalent |
| K864425 | RAYLOR(TM) DISSECTING HOOK | Dec 12, 1986 | Substantially Equivalent |
| K864424 | RAYLOR(TM) PROTECTIVE RETRACTOR | Nov 26, 1986 | Substantially Equivalent |
| K864426 | RAYLOR(TM) DEPTH GAUGE | Nov 26, 1986 | Substantially Equivalent |
| K864421 | RAYLOR(TM) PERIOSTEAL ELEVATORS | Nov 26, 1986 | Substantially Equivalent |
| K864423 | RAYLOR(TM) OSTEOTOMES | Nov 24, 1986 | Substantially Equivalent |
| K864422 | RAYLOR(TM) MALLET | Nov 24, 1986 | Substantially Equivalent |
| K863415 | RAYLOR BONE IMPACTORS | Sep 24, 1986 | Substantially Equivalent |