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FDA 510(k)

RAPIDFLAP CRANIAL CLAMP

K-Number: K991029 · 1999-04-23

ApplicantWalter Lorenz Surgical, Inc.
Decision Date1999-04-23
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RAPIDFLAP CRANIAL CLAMP 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 1999-04-23 under 510(k) number K991029. 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 RAPIDFLAP CRANIAL CLAMP?

RAPIDFLAP CRANIAL CLAMP is a medical device that received FDA 510(k) clearance on 1999-04-23. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K991029.

When did RAPIDFLAP CRANIAL CLAMP receive FDA 510(k) clearance?

RAPIDFLAP CRANIAL CLAMP received FDA 510(k) clearance on 1999-04-23, under 510(k) number K991029.

Who is the listed applicant for RAPIDFLAP CRANIAL CLAMP?

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 RAPIDFLAP CRANIAL CLAMP?

The FDA product code for RAPIDFLAP CRANIAL CLAMP 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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Related Devices (Code: GXN)

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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