FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHO-FRAC KIT
K Number: K811456
·
Decision Jun 12, 1981
Classifications
1
FEI Numbers
503
Registration Numbers
503
Same Product Code
51
Applicant Total
16
Review Days
21
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Basic Information
- Device Name
- ORTHO-FRAC KIT
- K Number
- K811456
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Orthomedics
- Date Received
- May 22, 1981
- Decision Date
- June 12, 1981
- Product Code
- IQI
- 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 |
|---|---|---|---|
| IQI | Orthosis, Limb Brace | FDA class 1 | Physical Medicine |
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Other Clearances by Orthomedics
| K Number | Device Name | ||
|---|---|---|---|
| K832740 | FEMORAL FRACTURE ORTHOSIS | Sep 20, 1983 | Substantially Equivalent |
| K832742 | EXTENSION CONTROL KNEE ORTHOSIS | Sep 20, 1983 | Substantially Equivalent |
| K832741 | JASON CERVICAL ORTHOSIS | Sep 20, 1983 | 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 |