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FDA 510(k)

LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM

K-Number: K982604 · 1998-10-23

ApplicantWalter Lorenz Surgical, Inc.
Decision Date1998-10-23
Product CodeMQN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LORENZ MAXILLA (LE FORT) DISTRACTION 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 1998-10-23 under 510(k) number K982604. The device is classified under product code MQN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM?

LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-23. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K982604.

When did LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM receive FDA 510(k) clearance?

LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM received FDA 510(k) clearance on 1998-10-23, under 510(k) number K982604.

Who is the listed applicant for LORENZ MAXILLA (LE FORT) DISTRACTION 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 MAXILLA (LE FORT) DISTRACTION SYSTEM?

The FDA product code for LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM is MQN.

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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.

K063386LORENZ ORTHODONTIC ANCHORAGE SYSTEMK063052LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATESK063506LORENZ STERNAL CLOSURE SYSTEMK062842TWIST DRILLK061384LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUMK042516OTOMIMIX

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Related Devices (Code: MQN)

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.

K220050KLS Martin IPS DistractionKLS Martin L.P.K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLCK181504Stryker Pediatric Mandibular Distractor 2StrykerK162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK161470Internal Distraction - SterileKLS Martin L.P.K121502SYNTHES CURVILINEAR DISTRACTION SYSTEMSynthes, 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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