FDA 510(k)

BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM

K-Number: K130274 · 2013-10-29

ApplicantElite Surgical Supplies (Pty), Ltd.

Decision Date2013-10-29

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. It received FDA 510(k) clearance on 2013-10-29 under 510(k) number K130274. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM?

BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-29. The listed applicant is Elite Surgical Supplies (Pty), Ltd.. The 510(k) number is K130274.

When did BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM receive FDA 510(k) clearance?

BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM received FDA 510(k) clearance on 2013-10-29, under 510(k) number K130274.

Who is the listed applicant for BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM?

The FDA 510(k) record lists Elite Surgical Supplies (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM?

The FDA product code for BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM is MAX.

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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.