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FDA 510(k)

STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE

K-Number: K926384 · 1993-11-16

ApplicantZimmer, Inc.
Decision Date1993-11-16
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1993-11-16 under 510(k) number K926384. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE?

STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE is a medical device that received FDA 510(k) clearance on 1993-11-16. The listed applicant is Zimmer, Inc.. The 510(k) number is K926384.

When did STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE receive FDA 510(k) clearance?

STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE received FDA 510(k) clearance on 1993-11-16, under 510(k) number K926384.

Who is the listed applicant for STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE?

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

What is the FDA product code for STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE?

The FDA product code for STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE is JDR.

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Related Devices (Code: JDR)

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K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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