510(k) K811297
K811297 is an FDA 510(k) premarket notification submitted by Orthomedics for the device "CERVICAL SUPPORT". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code IQF (Orthosis, Cervical-Thoracic, Rigid), a Class I device regulated under 21 CFR 890.3490. Orthomedics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1981
- Date Received
- May 11, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cervical-Thoracic, Rigid
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type