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FDA 510(k)

MEDNEXT 1000 DRILL

K-Number: K972308 · 1997-08-20

ApplicantMednext, Inc.
Decision Date1997-08-20
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDNEXT 1000 DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Mednext, Inc.. It received FDA 510(k) clearance on 1997-08-20 under 510(k) number K972308. 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 MEDNEXT 1000 DRILL?

MEDNEXT 1000 DRILL is a medical device that received FDA 510(k) clearance on 1997-08-20. The listed applicant is Mednext, Inc.. The 510(k) number is K972308.

When did MEDNEXT 1000 DRILL receive FDA 510(k) clearance?

MEDNEXT 1000 DRILL received FDA 510(k) clearance on 1997-08-20, under 510(k) number K972308.

Who is the listed applicant for MEDNEXT 1000 DRILL?

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

What is the FDA product code for MEDNEXT 1000 DRILL?

The FDA product code for MEDNEXT 1000 DRILL is GEY.

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Other records listing Mednext, 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.

K983092TRITON HUDSON CHUCK ATTACHMENTK970023MEDNEXT SURGICAL BURK943108MEDNEXT MICRO-DRILLK935861MEDNEXT BURK935584MEDNEXT BURK926547MEDNEXT 1000 BONE DISSECTING SYSTEM

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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)DepuyacromedK971941AQUA SPRAYBoyd Industries, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., Inc.K971268BONE & MARROW CLLECTION SYSTEMBiomedical International Corp.

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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