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FDA 510(k)

SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030

K-Number: K993073 · 1999-12-06

ApplicantBionx Implants, Ltd.
Decision Date1999-12-06
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Ltd.. It received FDA 510(k) clearance on 1999-12-06 under 510(k) number K993073. 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 SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030?

SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 is a medical device that received FDA 510(k) clearance on 1999-12-06. The listed applicant is Bionx Implants, Ltd.. The 510(k) number is K993073.

When did SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 receive FDA 510(k) clearance?

SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 received FDA 510(k) clearance on 1999-12-06, under 510(k) number K993073.

Who is the listed applicant for SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030?

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

What is the FDA product code for SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030?

The FDA product code for SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 is MAI.

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Other records listing Bionx Implants, Ltd. 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.

K030388IMPACT SUTURE ANCHOR. MODEL 433510K020056DUET SUTURE ANCHORK0120001.5MM BONE FIXATION KITK012001SMARTSCREWK003077SMARTSCREW MODEL 222006...227510K003757THERMOFX MESH

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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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