FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RAYLOR(TM) MALLET
K Number: K864422
·
Decision Nov 24, 1986
Classifications
1
FEI Numbers
304
Registration Numbers
304
Same Product Code
3
Applicant Total
17
Review Days
14
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Basic Information
- Device Name
- RAYLOR(TM) MALLET
- K Number
- K864422
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Cedar Surgical, Inc.
- Date Received
- November 10, 1986
- Decision Date
- November 24, 1986
- Product Code
- HWA
- 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 |
|---|---|---|---|
| HWA | Impactor | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWA), ordered by most recent decision date.
MODIFICATION OF ANTERIOR SEGMENT ELECTRODES
FDA 510(k)
FDA Class 1
·Orthopedic
MALLET
FDA 510(k)
FDA Class 1
·Orthopedic
CEMENT CHISELS
FDA 510(k)
FDA Class 1
·Orthopedic
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 |
| K863415 | RAYLOR BONE IMPACTORS | Sep 24, 1986 | Substantially Equivalent |