Clearance Summary
STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE received FDA 510(k) clearance under submission number K973031, sponsored by R. Thomas Grotz, M.D., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1997-11-03.
- Submission: K973031
- Applicant / Sponsor: R. Thomas Grotz, M.D., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3490
- Decision date: 1997-11-03
Classification & Regulation
This clearance is catalogued under FDA product code MRI and 21 CFR 890.3490, within the Physical Medicine review panel as a Class I device.