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FDA 510(k)

KLS Martin Cannulated Headless Screws

K-Number: K161259 · 2016-12-19

ApplicantKLS Martin L.P.
Decision Date2016-12-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KLS Martin Cannulated Headless Screws 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 2016-12-19 under 510(k) number K161259. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS Martin Cannulated Headless Screws?

KLS Martin Cannulated Headless Screws is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is KLS Martin L.P.. The 510(k) number is K161259.

When did KLS Martin Cannulated Headless Screws receive FDA 510(k) clearance?

KLS Martin Cannulated Headless Screws received FDA 510(k) clearance on 2016-12-19, under 510(k) number K161259.

Who is the listed applicant for KLS Martin Cannulated Headless Screws?

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 Cannulated Headless Screws?

The FDA product code for KLS Martin Cannulated Headless Screws is HWC. This falls under the Cardiovascular category.

Other records listing KLS Martin L.P. 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.

K254162KLS Martin Ixos SystemK253660KLS Martin Pure Pectus SystemK250988KLS Martin Pure Pectus SystemK250865KLS Martin IPS Forearm SystemK252573KLS 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) - STERILEK250620KLS Martin Ixos System

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Related Devices (Code: HWC)

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.

K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLCK261241TriMed Compression ScrewsTriMed, Inc.K254215Arthrex Beaming SystemArthrex, Inc.

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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