Clearance Summary
MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE received FDA 510(k) clearance under submission number K915139, sponsored by Micro Surgical Instruments Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1992-02-05.
- Submission: K915139
- Applicant / Sponsor: Micro Surgical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1992-02-05
Classification & Regulation
This clearance is catalogued under FDA product code HSZ and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.