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FDA 510(k)

BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM

K-Number: K971358 · 1997-07-09

ApplicantArthrex, Inc.
Decision Date1997-07-09
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 1997-07-09 under 510(k) number K971358. 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 BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM?

BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM is a medical device that received FDA 510(k) clearance on 1997-07-09. The listed applicant is Arthrex, Inc.. The 510(k) number is K971358.

When did BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM receive FDA 510(k) clearance?

BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM received FDA 510(k) clearance on 1997-07-09, under 510(k) number K971358.

Who is the listed applicant for BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM?

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

What is the FDA product code for BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM?

The FDA product code for BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM is MAI.

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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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