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FDA 510(k)

SELF-DRILLING RADIOGRAPHIC MARKER

K-Number: K014148 · 2002-01-17

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2002-01-17
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SELF-DRILLING RADIOGRAPHIC MARKER 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 2002-01-17 under 510(k) number K014148. 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 SELF-DRILLING RADIOGRAPHIC MARKER?

SELF-DRILLING RADIOGRAPHIC MARKER is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K014148.

When did SELF-DRILLING RADIOGRAPHIC MARKER receive FDA 510(k) clearance?

SELF-DRILLING RADIOGRAPHIC MARKER received FDA 510(k) clearance on 2002-01-17, under 510(k) number K014148.

Who is the listed applicant for SELF-DRILLING RADIOGRAPHIC MARKER?

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 SELF-DRILLING RADIOGRAPHIC MARKER?

The FDA product code for SELF-DRILLING RADIOGRAPHIC MARKER 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.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, 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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