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FDA 510(k)

KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)

K-Number: K040891 · 2004-05-28

ApplicantKLS-Martin L.P.
Decision Date2004-05-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) 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 2004-05-28 under 510(k) number K040891. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)?

KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is KLS-Martin L.P.. The 510(k) number is K040891.

When did KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) receive FDA 510(k) clearance?

KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) received FDA 510(k) clearance on 2004-05-28, under 510(k) number K040891.

Who is the listed applicant for KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)?

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 ORTHO ANCHORAGE SYSTEM (PLATES)?

The FDA product code for KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) is DZE.

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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: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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