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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 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 2017-05-05 under 510(k) 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. The listed applicant is KLS Martin L.P.. The 510(k) number is K163315.

When did Internal Distraction - Sterile receive FDA 510(k) clearance?

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

Who is the listed applicant for Internal Distraction - 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 Internal Distraction - Sterile?

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

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

View all 32 devices →

Related Devices (Code: PBJ)

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.

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

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