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FDA 510(k)

ERCH ARCH BAR, MODEL 38-690-00

K-Number: K061271 · 2006-06-30

ApplicantKLS-Martin L.P.
Decision Date2006-06-30
Product CodeDYX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ERCH ARCH BAR, MODEL 38-690-00 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 2006-06-30 under 510(k) number K061271. The device is classified under product code DYX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERCH ARCH BAR, MODEL 38-690-00?

ERCH ARCH BAR, MODEL 38-690-00 is a medical device that received FDA 510(k) clearance on 2006-06-30. The listed applicant is KLS-Martin L.P.. The 510(k) number is K061271.

When did ERCH ARCH BAR, MODEL 38-690-00 receive FDA 510(k) clearance?

ERCH ARCH BAR, MODEL 38-690-00 received FDA 510(k) clearance on 2006-06-30, under 510(k) number K061271.

Who is the listed applicant for ERCH ARCH BAR, MODEL 38-690-00?

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 ERCH ARCH BAR, MODEL 38-690-00?

The FDA product code for ERCH ARCH BAR, MODEL 38-690-00 is DYX.

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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

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Related Devices (Code: DYX)

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.

K162046MINNE TIES MMF Suture SystemSummit Medical, Inc.K031207SAFETY RELEASE ARCH BAR KITCasey Surgical, LLCK030605RAPID IMFZygomatics , Ltd.K990212LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00Doctor'S Research Group, Inc.K991004SYNTHES QUICK LOCK IMF SYSTEMSynthes (Usa)K925106IMPLANTABLE PULSE GENERATORSMedtronic Vascular

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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