510(k) K231483
K231483 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MySpine Unilateral Guides". The FDA issued a decision of Substantially Equivalent on July 21, 2023. The device falls under product code PQC (Pedicle Screw Placement Guide), a Class II device regulated under 21 CFR 888.3070. Medacta International S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2023
- Date Received
- May 23, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pedicle Screw Placement Guide
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.