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FDA 510(k)

INNOVASIVE SUTURE BONE FASTENER WITH SUTURE

K-Number: K935321 · 1994-10-19

ApplicantInnovasive Devices, Inc.
Decision Date1994-10-19
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INNOVASIVE SUTURE BONE FASTENER WITH SUTURE 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 1994-10-19 under 510(k) number K935321. 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 INNOVASIVE SUTURE BONE FASTENER WITH SUTURE?

INNOVASIVE SUTURE BONE FASTENER WITH SUTURE is a medical device that received FDA 510(k) clearance on 1994-10-19. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K935321.

When did INNOVASIVE SUTURE BONE FASTENER WITH SUTURE receive FDA 510(k) clearance?

INNOVASIVE SUTURE BONE FASTENER WITH SUTURE received FDA 510(k) clearance on 1994-10-19, under 510(k) number K935321.

Who is the listed applicant for INNOVASIVE SUTURE BONE FASTENER WITH SUTURE?

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 SUTURE BONE FASTENER WITH SUTURE?

The FDA product code for INNOVASIVE SUTURE BONE FASTENER WITH SUTURE is JDR.

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Other records listing Innovasive Devices, Inc. as applicant

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

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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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