FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUMBO-SACRAL FLEXION ORTHOSIS
K Number: K811494
·
Decision Jun 16, 1981
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
10
Applicant Total
9
Review Days
20
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Basic Information
- Device Name
- LUMBO-SACRAL FLEXION ORTHOSIS
- K Number
- K811494
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Surgical Appliance Industries, Inc.
- Date Received
- May 27, 1981
- Decision Date
- June 16, 1981
- Product Code
- IPY
- 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 |
|---|---|---|---|
| IPY | Orthosis, Lumbo-Sacral | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
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Other Clearances by Surgical Appliance Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121106 | TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET | Apr 27, 2012 | Substantially Equivalent |
| K821682 | TRUNCAL ORTHOSIS | Jun 24, 1982 | Substantially Equivalent |
| K813416 | EXTERNAL BREAST PROSTHESIS | Jan 18, 1982 | Substantially Equivalent |
| K812423 | NEOPRENE KNEE SUPPORT | Sep 14, 1981 | Substantially Equivalent |
| K812401 | CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O | Sep 14, 1981 | Substantially Equivalent |
| K812422 | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS | Sep 14, 1981 | Substantially Equivalent |
| K811689 | CYLINDER KNEE CAST/SPLINT | Jun 25, 1981 | Substantially Equivalent |
| K811690 | ANKLE-FOOT CAST/SPLINT | Jun 25, 1981 | Substantially Equivalent |