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FDA 510(k)

BME BONE DRILL BITS

K-Number: K964073 · 1996-11-14

ApplicantBiomedical Ent., Inc.
Decision Date1996-11-14
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BME BONE DRILL BITS is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Ent., Inc.. It received FDA 510(k) clearance on 1996-11-14 under 510(k) number K964073. The device is classified under product code GEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BME BONE DRILL BITS?

BME BONE DRILL BITS is a medical device that received FDA 510(k) clearance on 1996-11-14. The listed applicant is Biomedical Ent., Inc.. The 510(k) number is K964073.

When did BME BONE DRILL BITS receive FDA 510(k) clearance?

BME BONE DRILL BITS received FDA 510(k) clearance on 1996-11-14, under 510(k) number K964073.

Who is the listed applicant for BME BONE DRILL BITS?

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

What is the FDA product code for BME BONE DRILL BITS?

The FDA product code for BME BONE DRILL BITS is GEY.

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Other records listing Biomedical Ent., 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.

K131640SMOOTH OR THREADED METALLIC BONE FASTENERK102107OSSTAPLE CHILLK091951HAMMERLOCKK023203OSSTAPLEK001353MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEMK001354MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM

View all 11 devices →

Related Devices (Code: GEY)

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.

K050519ADVANCED TURBO DRIVE SYSTEMLinvatec Corp.K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp.K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)DepuyacromedK972308MEDNEXT 1000 DRILLMednext, Inc.K971941AQUA SPRAYBoyd Industries, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., 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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