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FDA 510(k)

INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER

K-Number: K970089 · 1997-03-25

ApplicantInnovasive Devices, Inc.
Decision Date1997-03-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER is the device name listed in this FDA 510(k) record. The listed applicant is Innovasive Devices, Inc.. It received FDA 510(k) clearance on 1997-03-25 under 510(k) number K970089. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER?

INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER is a medical device that received FDA 510(k) clearance on 1997-03-25. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K970089.

When did INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER receive FDA 510(k) clearance?

INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER received FDA 510(k) clearance on 1997-03-25, under 510(k) number K970089.

Who is the listed applicant for INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER?

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

What is the FDA product code for INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER?

The FDA product code for INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER is MBI.

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Other records listing Innovasive Devices, 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.

K994269TITAN RC TACKK993975ABSOLUTE ABSORBABLE INTERFERENCE SCREWK992458RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454K992377RC TACKK990454BIO-INTERFERENCE SCREWK984490SUTURELESS ANCHOR

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Related Devices (Code: MBI)

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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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