FDA 510(k)

LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES

K-Number: K063052 · 2007-01-12

Decision Date2007-01-12

Product CodeJEY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES 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 2007-01-12 under 510(k) number K063052. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES?

LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K063052.

When did LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES receive FDA 510(k) clearance?

LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES received FDA 510(k) clearance on 2007-01-12, under 510(k) number K063052.

Who is the listed applicant for LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES?

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 TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES?

The FDA product code for LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES is JEY.

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Other records listing Walter Lorenz Surgical, Inc. as applicant

K063386LORENZ ORTHODONTIC ANCHORAGE SYSTEM K063506LORENZ STERNAL CLOSURE SYSTEM K062842TWIST DRILL K061384LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM K042516OTOMIMIX K030425LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER

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Related Devices (Code: JEY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.