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FDA 510(k)

LORENZ PECTUS SUPPORT BAR STABILIZER

K-Number: K981789 · 1998-07-13

ApplicantWalter Lorenz Surgical, Inc.
Decision Date1998-07-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LORENZ PECTUS SUPPORT BAR STABILIZER 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 1998-07-13 under 510(k) number K981789. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORENZ PECTUS SUPPORT BAR STABILIZER?

LORENZ PECTUS SUPPORT BAR STABILIZER is a medical device that received FDA 510(k) clearance on 1998-07-13. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K981789.

When did LORENZ PECTUS SUPPORT BAR STABILIZER receive FDA 510(k) clearance?

LORENZ PECTUS SUPPORT BAR STABILIZER received FDA 510(k) clearance on 1998-07-13, under 510(k) number K981789.

Who is the listed applicant for LORENZ PECTUS SUPPORT BAR STABILIZER?

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 PECTUS SUPPORT BAR STABILIZER?

The FDA product code for LORENZ PECTUS SUPPORT BAR STABILIZER is HRS.

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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: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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