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

FDA 510(k)

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers

K-Number: K172587 · 2017-09-18

ApplicantMedacta International S.A.
Decision Date2017-09-18
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-09-18 under approval number K172587. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers?

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers is a medical device that received FDA 510(k) clearance on 2017-09-18. It is manufactured by Medacta International S.A.. The 510(k) number is K172587.

When was Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers approved by the FDA?

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers received FDA 510(k) clearance on 2017-09-18, under approval number K172587.

What company makes Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers?

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers is manufactured by Medacta International S.A..

What is the FDA product code for Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers?

The FDA product code for Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers is ODP.

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

View all 146 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.

↑