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FDA 510(k)

PATIENT CONTOURED MESH (PCM)

K-Number: K062570 · 2006-10-31

ApplicantKLS-Martin L.P.
Decision Date2006-10-31
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PATIENT CONTOURED MESH (PCM) 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 2006-10-31 under 510(k) number K062570. 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 (PCM)?

PATIENT CONTOURED MESH (PCM) is a medical device that received FDA 510(k) clearance on 2006-10-31. The listed applicant is KLS-Martin L.P.. The 510(k) number is K062570.

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

PATIENT CONTOURED MESH (PCM) received FDA 510(k) clearance on 2006-10-31, under 510(k) number K062570.

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

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 (PCM)?

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

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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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsK254162KLS 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) - STERILE

View all 75 devices →

Related Devices (Code: GXN)

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.

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 SolutionsK2531163D 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 GmbHK252573KLS 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.

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