FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WILSON SPINAL FRAME
K Number: K761036
·
Decision Dec 16, 1976
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
0
Applicant Total
45
Review Days
31
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Basic Information
- Device Name
- WILSON SPINAL FRAME
- K Number
- K761036
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5890
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Orthopedic Equipment Co., Inc.
- Date Received
- November 15, 1976
- Decision Date
- December 16, 1976
- Product Code
- HSQ
- 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 |
|---|---|---|---|
| HSQ | Belt, Pelvic, Traction | FDA class 1 | Orthopedic |
Other Clearances by Orthopedic Equipment Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834035 | UNIVERSAL SELF-ALIGNING ACETABULAR COM | Jun 19, 1984 | Substantially Equivalent |
| K841189 | OEC/REZAIAN SPINAL FIXATOR | May 16, 1984 | Substantially Equivalent |
| K800530 | SCHLEIN TRI-SURFACE ANKLE | Apr 2, 1980 | Substantially Equivalent |
| K781445 | SPREADER | Sep 27, 1979 | Substantially Equivalent |
| K790247 | TOURNIQUET TEST GAGE | Feb 26, 1979 | Substantially Equivalent |
| K790209 | FILTER SYSTEM, ALTNER DISPOSABLE | Feb 26, 1979 | Substantially Equivalent |
| K781450 | DRIVERS | Sep 27, 1978 | Substantially Equivalent |
| K781444 | OUTRIGGER DISTRACTION UNIT | Sep 27, 1978 | Substantially Equivalent |
| K781451 | FLAT WRENCH | Sep 27, 1978 | Substantially Equivalent |
| K781447 | THREADED ROD CLAMP | Sep 27, 1978 | Substantially Equivalent |