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FDA 510(k)

ROTORBLADE

K-Number: K983435 · 1999-04-29

ApplicantLi Medical Technologies, Inc.
Decision Date1999-04-29
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROTORBLADE 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 1999-04-29 under 510(k) number K983435. 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?

ROTORBLADE is a medical device that received FDA 510(k) clearance on 1999-04-29. The listed applicant is Li Medical Technologies, Inc.. The 510(k) number is K983435.

When did ROTORBLADE receive FDA 510(k) clearance?

ROTORBLADE received FDA 510(k) clearance on 1999-04-29, under 510(k) number K983435.

Who is the listed applicant for ROTORBLADE?

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?

The FDA product code for ROTORBLADE 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 ANCHORK992938ROTORBLADE SUTURE ANCHORK981755LM ANCHORK981764LM ANCHORK963288LM BONE ANCHOR

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Related Devices (Code: MAI)

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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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