FDA 510(k)
Substantially Equivalent
🇺🇸 United States
FEMORAL FRACTURE ORTHOSIS
K Number: K832740
·
Decision Sep 20, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
16
Review Days
36
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Basic Information
- Device Name
- FEMORAL FRACTURE ORTHOSIS
- K Number
- K832740
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Orthomedics
- Date Received
- August 15, 1983
- Decision Date
- September 20, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by Orthomedics
| K Number | Device Name | ||
|---|---|---|---|
| K832742 | EXTENSION CONTROL KNEE ORTHOSIS | Sep 20, 1983 | Substantially Equivalent |
| K832741 | JASON CERVICAL ORTHOSIS | Sep 20, 1983 | Substantially Equivalent |
| K811456 | ORTHO-FRAC KIT | Jun 12, 1981 | Substantially Equivalent |
| K811298 | EXECUTIVE COLLAR | May 27, 1981 | Substantially Equivalent |
| K811297 | CERVICAL SUPPORT | May 27, 1981 | Substantially Equivalent |
| K810555 | SCOLIOSIS ORTHOTIC SYSTEM | Mar 13, 1981 | Substantially Equivalent |
| K810557 | HIP ABDUCTION SPLINT | Mar 13, 1981 | Substantially Equivalent |
| K810554 | LUMBAR FLEXION BRACE | Mar 13, 1981 | Substantially Equivalent |
| K810556 | SPINAL EXTENSION BRACE | Mar 13, 1981 | Substantially Equivalent |
| K803033 | CRUSADER HYPEREXTENSION BRACE | Dec 22, 1980 | Substantially Equivalent |