Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GLENOID DRILL

K-Number: K863147 · 1986-09-05

ApplicantBowen & Company, Inc.
Decision Date1986-09-05
Product CodeHTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GLENOID DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Bowen & Company, Inc.. It received FDA 510(k) clearance on 1986-09-05 under 510(k) number K863147. The device is classified under product code HTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLENOID DRILL?

GLENOID DRILL is a medical device that received FDA 510(k) clearance on 1986-09-05. The listed applicant is Bowen & Company, Inc.. The 510(k) number is K863147.

When did GLENOID DRILL receive FDA 510(k) clearance?

GLENOID DRILL received FDA 510(k) clearance on 1986-09-05, under 510(k) number K863147.

Who is the listed applicant for GLENOID DRILL?

The FDA 510(k) record lists Bowen & Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLENOID DRILL?

The FDA product code for GLENOID DRILL is HTW.

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 Bowen & Company, 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.

K896898BOWEN ELECTRODE SKIN PREPATORY CLEANSERK896538DISPOSABLE 45 DEGREE SHAVERK873766STERNAL POWER AWLK872098CREMEEN ALVEOLAR BONE CALIPERK871325BOWEN REUSEABLE/DISPOSABLE ELECTRODEK87088245 DEGREE SHAVER

View all 14 devices →

Related Devices (Code: HTW)

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.

K151661Renovo Life Hard Carbon Coated Drill BitRenovo Life, LLCK942906AGEE-WRISTJACK PRE-DRILL KITHand Biomechanics Lab, Inc.K930339REAMER BITNeoligaments, Ltd.K915692CANNULATED DRILL BITW. L. Gore & Associates, Inc.K892903MITEK ANCHOR DRILLMitek Surgical Products, Inc.K870217FEMORAL CEMENT REMOVAL INSTRUMENTSKenneth J. Hoek, M.D., Inc.

Official Source

View on FDA Database →

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

↑