FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SACRAL BAR
K Number: K843445
·
Decision Feb 13, 1985
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
5
Review Days
161
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Basic Information
- Device Name
- SACRAL BAR
- K Number
- K843445
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Stuart
- Date Received
- September 5, 1984
- Decision Date
- February 13, 1985
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 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 |
| K851414 | SEGMENTAL SPINAL RODS | Jun 28, 1985 | Substantially Equivalent |
| K820034 | ANTERIOR DISTRACTION SYSTEM | Mar 11, 1982 | Substantially Equivalent |