FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEGMENTAL SPINAL RODS
K Number: K851414
·
Decision Jun 28, 1985
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
5
Review Days
80
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Basic Information
- Device Name
- SEGMENTAL SPINAL RODS
- K Number
- K851414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Stuart
- Date Received
- April 9, 1985
- Decision Date
- June 28, 1985
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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Other Clearances by Stuart
| K Number | Device Name | ||
|---|---|---|---|
| K897141 | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | Jun 21, 1990 | Substantially Equivalent for Some Indications |
| K890601 | STUART TITANIUM SURGICAL MESH | Mar 16, 1989 | Substantially Equivalent |
| K843445 | SACRAL BAR | Feb 13, 1985 | Substantially Equivalent |
| K820034 | ANTERIOR DISTRACTION SYSTEM | Mar 11, 1982 | Substantially Equivalent |