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FDA 510(k)

LIGAFIX INTERFERENCE SCREW

K-Number: K122228 · 2012-10-03

ApplicantSbm Sciences For Bio Materials
Decision Date2012-10-03
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIGAFIX INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Sbm Sciences For Bio Materials. It received FDA 510(k) clearance on 2012-10-03 under 510(k) number K122228. 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 LIGAFIX INTERFERENCE SCREW?

LIGAFIX INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2012-10-03. The listed applicant is Sbm Sciences For Bio Materials. The 510(k) number is K122228.

When did LIGAFIX INTERFERENCE SCREW receive FDA 510(k) clearance?

LIGAFIX INTERFERENCE SCREW received FDA 510(k) clearance on 2012-10-03, under 510(k) number K122228.

Who is the listed applicant for LIGAFIX INTERFERENCE SCREW?

The FDA 510(k) record lists Sbm Sciences For Bio Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIGAFIX INTERFERENCE SCREW?

The FDA product code for LIGAFIX INTERFERENCE SCREW is MAI.

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Other records listing Sbm Sciences For Bio Materials 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.

K130953NEOTIS; NEOTIS 50

Related Devices (Code: MAI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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