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FDA 510(k)

SOFT TISSUE ANCHORING WASHERS

K-Number: K030031 · 2003-01-28

ApplicantAccu-Speed, Incorporated
Decision Date2003-01-28
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFT TISSUE ANCHORING WASHERS is the device name listed in this FDA 510(k) record. The listed applicant is Accu-Speed, Incorporated. It received FDA 510(k) clearance on 2003-01-28 under 510(k) number K030031. The device is classified under product code KGS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT TISSUE ANCHORING WASHERS?

SOFT TISSUE ANCHORING WASHERS is a medical device that received FDA 510(k) clearance on 2003-01-28. The listed applicant is Accu-Speed, Incorporated. The 510(k) number is K030031.

When did SOFT TISSUE ANCHORING WASHERS receive FDA 510(k) clearance?

SOFT TISSUE ANCHORING WASHERS received FDA 510(k) clearance on 2003-01-28, under 510(k) number K030031.

Who is the listed applicant for SOFT TISSUE ANCHORING WASHERS?

The FDA 510(k) record lists Accu-Speed, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFT TISSUE ANCHORING WASHERS?

The FDA product code for SOFT TISSUE ANCHORING WASHERS is KGS.

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Related Devices (Code: KGS)

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.

K020480RBMSmith & Nephew, Inc.K964935SUTURE LOCKSmith & Nephew Endoscopy, Inc.K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, Inc.K911225TRAY DOUGHThe Hygenic 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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