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FDA 510(k)

Internal Distraction - Sterile

K-Number: K163315 · 2017-05-05

ApplicantKLS Martin L.P.
Decision Date2017-05-05
Product CodePBJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Internal Distraction - Sterile is a medical device manufactured by KLS Martin L.P.. It received FDA 510(k) clearance on 2017-05-05 under approval number K163315. The device is classified under product code PBJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Internal Distraction - Sterile?

Internal Distraction - Sterile is a medical device that received FDA 510(k) clearance on 2017-05-05. It is manufactured by KLS Martin L.P.. The 510(k) number is K163315.

When was Internal Distraction - Sterile approved by the FDA?

Internal Distraction - Sterile received FDA 510(k) clearance on 2017-05-05, under approval number K163315.

What company makes Internal Distraction - Sterile?

Internal Distraction - Sterile is manufactured by KLS Martin L.P..

What is the FDA product code for Internal Distraction - Sterile?

The FDA product code for Internal Distraction - Sterile is PBJ.

Other Devices by KLS Martin L.P.

K161259KLS Martin Cannulated Headless Screws K161470Internal Distraction - Sterile K151983KLS Martin LSS Plating System K163579KLS Martin Individual Patient Solutions K170124Level One Hand Plating System K173320KLS Martin L1 MMF System

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Related Devices (Code: PBJ)

K170818Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC K230211CranioXpandKLS-Martin L.P.

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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