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FDA 510(k)

BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR

K-Number: K972783 · 1998-04-14

ApplicantBionx Implants, Inc.
Decision Date1998-04-14
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Inc.. It received FDA 510(k) clearance on 1998-04-14 under 510(k) number K972783. 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 BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR?

BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 1998-04-14. The listed applicant is Bionx Implants, Inc.. The 510(k) number is K972783.

When did BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR receive FDA 510(k) clearance?

BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR received FDA 510(k) clearance on 1998-04-14, under 510(k) number K972783.

Who is the listed applicant for BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR?

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

What is the FDA product code for BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR?

The FDA product code for BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR is MAI.

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Other records listing Bionx Implants, Inc. as applicant

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K023022NUGEN FX SCREWK011569BIOSORBFX O/M 2.0/2/4 SYSTEMK013546MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214K013057BIOCUFF,C, MODELS 236018, 236028, 236036K012334CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116K010983PLLA PIN

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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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