FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXTENSION CONTROL KNEE ORTHOSIS
K Number: K832742
·
Decision Sep 20, 1983
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
4
Applicant Total
16
Review Days
36
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Basic Information
- Device Name
- EXTENSION CONTROL KNEE ORTHOSIS
- K Number
- K832742
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Orthomedics
- Date Received
- August 15, 1983
- Decision Date
- September 20, 1983
- Product Code
- ITM
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ITM | Cage, Knee | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITM), ordered by most recent decision date.
POLI-AXIAL KNEE CAGE
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CAST BRWM, FRACTURE
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FRACTURE CAST BRACE, POLY
FDA 510(k)
FDA Class 1
·Physical Medicine
IMPROVED KNEE DRESSING
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Orthomedics
| K Number | Device Name | ||
|---|---|---|---|
| K832740 | FEMORAL FRACTURE 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 |