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FDA 510(k)

SINEFIX

K-Number: K220966 · 2023-03-08

ApplicantBAAT Medical Products B.V.
Decision Date2023-03-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SINEFIX is the device name listed in this FDA 510(k) record. The listed applicant is BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K220966. 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 SINEFIX?

SINEFIX is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is BAAT Medical Products B.V.. The 510(k) number is K220966.

When did SINEFIX receive FDA 510(k) clearance?

SINEFIX received FDA 510(k) clearance on 2023-03-08, under 510(k) number K220966.

Who is the listed applicant for SINEFIX?

The FDA 510(k) record lists BAAT Medical Products B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINEFIX?

The FDA product code for SINEFIX is MBI.

Related Clinical Trials

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.

NCT05721560SINEFIX-2022 Pilot PhaseACTIVE_NOT_RECRUITINGNCT06818448SINEFIX-2022 Comparative PhaseRECRUITING

Other records listing BAAT Medical Products B.V. 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.

K254176SINEFIXK251961SDS Growing RodK211474Kleiner KG2 SystemK201830ANSER Clavicle Pin

Related Devices (Code: MBI)

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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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