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FDA 510(k)

KLS Martin IPS Preprosthetic

K-Number: K210228 · 2022-07-08

ApplicantKLS-Martin L.P.
Decision Date2022-07-08
Product CodeELE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS Martin IPS Preprosthetic 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 2022-07-08 under 510(k) number K210228. The device is classified under product code ELE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS Martin IPS Preprosthetic?

KLS Martin IPS Preprosthetic is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is KLS-Martin L.P.. The 510(k) number is K210228.

When did KLS Martin IPS Preprosthetic receive FDA 510(k) clearance?

KLS Martin IPS Preprosthetic received FDA 510(k) clearance on 2022-07-08, under 510(k) number K210228.

Who is the listed applicant for KLS Martin IPS Preprosthetic?

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 IPS Preprosthetic?

The FDA product code for KLS Martin IPS Preprosthetic is ELE.

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 →

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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