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)

DRILL BIT

K-Number: K841629 · 1984-08-27

ApplicantPlastafil, Inc.
Decision Date1984-08-27
Product CodeHTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DRILL BIT is the device name listed in this FDA 510(k) record. The listed applicant is Plastafil, Inc.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K841629. 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 DRILL BIT?

DRILL BIT is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Plastafil, Inc.. The 510(k) number is K841629.

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

DRILL BIT received FDA 510(k) clearance on 1984-08-27, under 510(k) number K841629.

Who is the listed applicant for DRILL BIT?

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

What is the FDA product code for DRILL BIT?

The FDA product code for DRILL BIT 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 Plastafil, 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.

K841621BACK RADIUS CUTTERK841620FRONT RADIUS CUTTERK841625HOOKK841617STROVER HOOKK841626PUNCHK841627MALLET

View all 13 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.

↑