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FDA 510(k)

MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS

K-Number: K040990 · 2004-05-13

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2004-05-13
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS 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 2004-05-13 under 510(k) number K040990. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS?

MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS is a medical device that received FDA 510(k) clearance on 2004-05-13. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K040990.

When did MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS receive FDA 510(k) clearance?

MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS received FDA 510(k) clearance on 2004-05-13, under 510(k) number K040990.

Who is the listed applicant for MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS?

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 MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS?

The FDA product code for MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS is NEU.

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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: NEU)

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.

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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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