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FDA 510(k)

REAMER BIT

K-Number: K930339 · 1993-08-06

ApplicantNeoligaments, Ltd.
Decision Date1993-08-06
Product CodeHTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REAMER BIT is the device name listed in this FDA 510(k) record. The listed applicant is Neoligaments, Ltd.. It received FDA 510(k) clearance on 1993-08-06 under 510(k) number K930339. 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 REAMER BIT?

REAMER BIT is a medical device that received FDA 510(k) clearance on 1993-08-06. The listed applicant is Neoligaments, Ltd.. The 510(k) number is K930339.

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

REAMER BIT received FDA 510(k) clearance on 1993-08-06, under 510(k) number K930339.

Who is the listed applicant for REAMER BIT?

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

What is the FDA product code for REAMER BIT?

The FDA product code for REAMER BIT is HTW.

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Other records listing Neoligaments, Ltd. 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.

K941772CRADLE FIXATION DEVICEK952543GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SETK935753THE GRAFTOLOGERK913461FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEMK911445FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEMK904340FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM

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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.K915692CANNULATED DRILL BITW. L. Gore & Associates, Inc.K892903MITEK ANCHOR DRILLMitek Surgical Products, Inc.K870217FEMORAL CEMENT REMOVAL INSTRUMENTSKenneth J. Hoek, M.D., Inc.K863147GLENOID DRILLBowen & Company, 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.

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