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FDA 510(k)

KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN

K-Number: K961522 · 1996-09-23

ApplicantSynvasive Technology, Inc.
Decision Date1996-09-23
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN 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 1996-09-23 under 510(k) number K961522. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN?

KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN is a medical device that received FDA 510(k) clearance on 1996-09-23. The listed applicant is Synvasive Technology, Inc.. The 510(k) number is K961522.

When did KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN receive FDA 510(k) clearance?

KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN received FDA 510(k) clearance on 1996-09-23, under 510(k) number K961522.

Who is the listed applicant for KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN?

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 KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN?

The FDA product code for KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN is HTY.

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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 BALANCERK972508SURGICAL BURS AND SURGICAL DRILL BITSK950009POWERGRIP(TM) COMPRESSION FIXATION DEVICEK934336SPINALPLANEK933933CEBOPLANE

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Related Devices (Code: HTY)

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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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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