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FDA 510(k)

SURGICAL BURS AND SURGICAL DRILL BITS

K-Number: K972508 · 1997-08-26

ApplicantSynvasive Technology, Inc.
Decision Date1997-08-26
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL BURS AND SURGICAL DRILL BITS is the device name listed in this FDA 510(k) record. The listed applicant is Synvasive Technology, Inc.. It received FDA 510(k) clearance on 1997-08-26 under 510(k) number K972508. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL BURS AND SURGICAL DRILL BITS?

SURGICAL BURS AND SURGICAL DRILL BITS is a medical device that received FDA 510(k) clearance on 1997-08-26. The listed applicant is Synvasive Technology, Inc.. The 510(k) number is K972508.

When did SURGICAL BURS AND SURGICAL DRILL BITS receive FDA 510(k) clearance?

SURGICAL BURS AND SURGICAL DRILL BITS received FDA 510(k) clearance on 1997-08-26, under 510(k) number K972508.

Who is the listed applicant for SURGICAL BURS AND SURGICAL DRILL BITS?

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

What is the FDA product code for SURGICAL BURS AND SURGICAL DRILL BITS?

The FDA product code for SURGICAL BURS AND SURGICAL DRILL BITS is HWE.

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Other records listing Synvasive Technology, Inc. as applicant

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K093046ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZESK070108ELIBRA DYNAMIC KNEE BALANCERK961522KIRSCHNER WIRE (K-WIRE) AND STEINMANN PINK950009POWERGRIP(TM) COMPRESSION FIXATION DEVICEK934336SPINALPLANEK933933CEBOPLANE

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Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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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