FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAYLOR BONE IMPACTORS
K Number: K863415
·
Decision Sep 24, 1986
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
33
Applicant Total
17
Review Days
21
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Basic Information
- Device Name
- RAYLOR BONE IMPACTORS
- K Number
- K863415
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4535
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Cedar Surgical, Inc.
- Date Received
- September 3, 1986
- Decision Date
- September 24, 1986
- Product Code
- HAO
- 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 |
|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | FDA class 1 | Neurology |
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Other Clearances by Cedar Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873692 | RAYLOR(TM) DRILL STOP | Dec 17, 1987 | Substantially Equivalent |
| 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 |