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FDA 510(k)

LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER

K-Number: K030425 · 2004-05-14

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2004-05-14
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER 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 2004-05-14 under 510(k) number K030425. 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 RESORBABLE DISTRACTION SYSTEM OR EXPANDER?

LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER is a medical device that received FDA 510(k) clearance on 2004-05-14. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K030425.

When did LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER receive FDA 510(k) clearance?

LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER received FDA 510(k) clearance on 2004-05-14, under 510(k) number K030425.

Who is the listed applicant for LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER?

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 RESORBABLE DISTRACTION SYSTEM OR EXPANDER?

The FDA product code for LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER is JEY.

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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: JEY)

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 SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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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