FDA 510(k)

KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE

K-Number: K070169 · 2007-03-26

Decision Date2007-03-26

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is KLS Martin L.P.. It received FDA 510(k) clearance on 2007-03-26 under 510(k) number K070169. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE?

KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE is a medical device that received FDA 510(k) clearance on 2007-03-26. The listed applicant is KLS Martin L.P.. The 510(k) number is K070169.

When did KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE receive FDA 510(k) clearance?

KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE received FDA 510(k) clearance on 2007-03-26, under 510(k) number K070169.

Who is the listed applicant for KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE?

The FDA 510(k) record lists KLS Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE?

The FDA product code for KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE is HRS.

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Other records listing KLS Martin L.P. as applicant

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions K254162KLS Martin Ixos System K253660KLS Martin Pure Pectus System K250988KLS Martin Pure Pectus System K250865KLS Martin IPS Forearm System K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

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Related Devices (Code: HRS)

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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.