FDA 510(k)

PATIENT CONTOURED MESH-PEEK (PCM-P)

K-Number: K072707 · 2007-12-19

Decision Date2007-12-19

Product CodeGXN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PATIENT CONTOURED MESH-PEEK (PCM-P) 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 2007-12-19 under 510(k) number K072707. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT CONTOURED MESH-PEEK (PCM-P)?

PATIENT CONTOURED MESH-PEEK (PCM-P) is a medical device that received FDA 510(k) clearance on 2007-12-19. The listed applicant is KLS-Martin L.P.. The 510(k) number is K072707.

When did PATIENT CONTOURED MESH-PEEK (PCM-P) receive FDA 510(k) clearance?

PATIENT CONTOURED MESH-PEEK (PCM-P) received FDA 510(k) clearance on 2007-12-19, under 510(k) number K072707.

Who is the listed applicant for PATIENT CONTOURED MESH-PEEK (PCM-P)?

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 PATIENT CONTOURED MESH-PEEK (PCM-P)?

The FDA product code for PATIENT CONTOURED MESH-PEEK (PCM-P) is GXN.

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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: GXN)

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)Longeviti Neuro Solutions K2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.K243715Synthes Patient Specific ImplantsSynthes GmbH 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) - STERILEKLS-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.