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FDA 510(k)

SPIN DOWN RAPIDFLAP

K-Number: K031034 · 2003-05-21

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2003-05-21
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPIN DOWN RAPIDFLAP 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 2003-05-21 under 510(k) number K031034. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIN DOWN RAPIDFLAP?

SPIN DOWN RAPIDFLAP is a medical device that received FDA 510(k) clearance on 2003-05-21. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K031034.

When did SPIN DOWN RAPIDFLAP receive FDA 510(k) clearance?

SPIN DOWN RAPIDFLAP received FDA 510(k) clearance on 2003-05-21, under 510(k) number K031034.

Who is the listed applicant for SPIN DOWN RAPIDFLAP?

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 SPIN DOWN RAPIDFLAP?

The FDA product code for SPIN DOWN RAPIDFLAP is GXN.

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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

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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