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FDA 510(k)

STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8

K-Number: K964927 · 1997-02-07

ApplicantR. Thomas Grotz, M.D., Inc.
Decision Date1997-02-07
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 is the device name listed in this FDA 510(k) record. The listed applicant is R. Thomas Grotz, M.D., Inc.. It received FDA 510(k) clearance on 1997-02-07 under 510(k) number K964927. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8?

STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 is a medical device that received FDA 510(k) clearance on 1997-02-07. The listed applicant is R. Thomas Grotz, M.D., Inc.. The 510(k) number is K964927.

When did STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 receive FDA 510(k) clearance?

STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 received FDA 510(k) clearance on 1997-02-07, under 510(k) number K964927.

Who is the listed applicant for STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8?

The FDA 510(k) record lists R. Thomas Grotz, M.D., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8?

The FDA product code for STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 is MBI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing R. Thomas Grotz, M.D., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K984200STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZEK973031STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTEK965111STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008

Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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