510(k) K222903
K222903 is an FDA 510(k) premarket notification submitted by Bespoke Technologies, LLC for the device "Tailored-H Cervical Stand Alone System". The FDA issued a decision of Substantially Equivalent on Nov 18, 2022. The device falls under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical), a Class II device regulated under 21 CFR 888.3080. Bespoke Technologies, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2022
- Date Received
- Sep 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.