510(k) K132575
K132575 is an FDA 510(k) premarket notification submitted by Medicrea International for the device "PASS LP SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 3, 2013. The device falls under product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis), a Class II device regulated under 21 CFR 888.3070. Medicrea International has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2013
- Date Received
- August 16, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.