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FDA 510(k)

ROTORBLADE SUTURE ANCHOR

K-Number: K992938 · 1999-09-23

ApplicantLi Medical Technologies, Inc.
Decision Date1999-09-23
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROTORBLADE SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Li Medical Technologies, Inc.. It received FDA 510(k) clearance on 1999-09-23 under 510(k) number K992938. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTORBLADE SUTURE ANCHOR?

ROTORBLADE SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 1999-09-23. The listed applicant is Li Medical Technologies, Inc.. The 510(k) number is K992938.

When did ROTORBLADE SUTURE ANCHOR receive FDA 510(k) clearance?

ROTORBLADE SUTURE ANCHOR received FDA 510(k) clearance on 1999-09-23, under 510(k) number K992938.

Who is the listed applicant for ROTORBLADE SUTURE ANCHOR?

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

What is the FDA product code for ROTORBLADE SUTURE ANCHOR?

The FDA product code for ROTORBLADE SUTURE ANCHOR is MAI.

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Other records listing Li Medical Technologies, 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.

K002413ULTRASORB SUTURE ANCHORK993373ROTORBLADE SUTURE ANCHORK983435ROTORBLADEK981755LM ANCHORK981764LM ANCHORK963288LM BONE ANCHOR

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Related Devices (Code: MAI)

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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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