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FDA 510(k)

LORENZ ORTHODONTIC ANCHORAGE SYSTEM

K-Number: K063386 · 2007-02-09

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2007-02-09
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LORENZ ORTHODONTIC ANCHORAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Walter Lorenz Surgical, Inc.. It received FDA 510(k) clearance on 2007-02-09 under 510(k) number K063386. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORENZ ORTHODONTIC ANCHORAGE SYSTEM?

LORENZ ORTHODONTIC ANCHORAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-02-09. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K063386.

When did LORENZ ORTHODONTIC ANCHORAGE SYSTEM receive FDA 510(k) clearance?

LORENZ ORTHODONTIC ANCHORAGE SYSTEM received FDA 510(k) clearance on 2007-02-09, under 510(k) number K063386.

Who is the listed applicant for LORENZ ORTHODONTIC ANCHORAGE SYSTEM?

The FDA 510(k) record lists Walter Lorenz Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LORENZ ORTHODONTIC ANCHORAGE SYSTEM?

The FDA product code for LORENZ ORTHODONTIC ANCHORAGE SYSTEM is OAT.

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Other records listing Walter Lorenz Surgical, Inc. 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.

K063052LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATESK063506LORENZ STERNAL CLOSURE SYSTEMK062842TWIST DRILLK061384LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUMK042516OTOMIMIXK030425LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER

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Related Devices (Code: OAT)

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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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