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FDA 510(k)

Simparo Anchor Line Fixation System

K-Number: K222574 · 2023-02-04

ApplicantSimparo, Inc.
Decision Date2023-02-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Simparo Anchor Line Fixation System is a medical device manufactured by Simparo, Inc.. It received FDA 510(k) clearance on 2023-02-04 under approval number K222574. 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 Simparo Anchor Line Fixation System?

Simparo Anchor Line Fixation System is a medical device that received FDA 510(k) clearance on 2023-02-04. It is manufactured by Simparo, Inc.. The 510(k) number is K222574.

When was Simparo Anchor Line Fixation System approved by the FDA?

Simparo Anchor Line Fixation System received FDA 510(k) clearance on 2023-02-04, under approval number K222574.

What company makes Simparo Anchor Line Fixation System?

Simparo Anchor Line Fixation System is manufactured by Simparo, Inc..

What is the FDA product code for Simparo Anchor Line Fixation System?

The FDA product code for Simparo Anchor Line Fixation System is MBI.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT07587593 The IVCare Adaptive Platform Trial NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED

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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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