Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MECTALIF ANTERIOR

K-Number: K124034 · 2013-05-17

ApplicantMedacta International
Decision Date2013-05-17
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MECTALIF ANTERIOR is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K124034. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECTALIF ANTERIOR?

MECTALIF ANTERIOR is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Medacta International. The 510(k) number is K124034.

When did MECTALIF ANTERIOR receive FDA 510(k) clearance?

MECTALIF ANTERIOR received FDA 510(k) clearance on 2013-05-17, under 510(k) number K124034.

Who is the listed applicant for MECTALIF ANTERIOR?

The FDA 510(k) record lists Medacta International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MECTALIF ANTERIOR?

The FDA product code for MECTALIF ANTERIOR is OVD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medacta International 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.

K160605MectaLIF Anterior Stand-AloneK160289MasterLoc StemK153664M.U.S.T. Pedicle Screw SystemK133630GMK SHORT STEMK132878M.U.S.T. EXTENSIONK131518MECTACER BIOLOX OPTION HEADS

View all 28 devices →

Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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.

↑