Clearance Summary
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) received FDA 510(k) clearance under submission number K141385, sponsored by Depuy Synthes Companies of Johnson & Johnson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-03-27.
- Submission: K141385
- Applicant / Sponsor: Depuy Synthes Companies of Johnson & Johnson
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5360
- Decision date: 2015-03-27
Classification & Regulation
This clearance is catalogued under FDA product code HBW and 21 CFR 882.5360, within the Neurology review panel as a Class II device.