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FDA 510(k)

LORENZ STERNAL CLOSURE SYSTEM

K-Number: K033740 · 2003-12-15

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2003-12-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LORENZ STERNAL CLOSURE 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 2003-12-15 under 510(k) number K033740. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORENZ STERNAL CLOSURE SYSTEM?

LORENZ STERNAL CLOSURE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-15. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K033740.

When did LORENZ STERNAL CLOSURE SYSTEM receive FDA 510(k) clearance?

LORENZ STERNAL CLOSURE SYSTEM received FDA 510(k) clearance on 2003-12-15, under 510(k) number K033740.

Who is the listed applicant for LORENZ STERNAL CLOSURE 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 STERNAL CLOSURE SYSTEM?

The FDA product code for LORENZ STERNAL CLOSURE SYSTEM is HWC. This falls under the Cardiovascular category.

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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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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.

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