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FDA 510(k)

LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW

K-Number: K013557 · 2001-11-16

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2001-11-16
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW 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 2001-11-16 under 510(k) number K013557. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW?

LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K013557.

When did LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW receive FDA 510(k) clearance?

LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW received FDA 510(k) clearance on 2001-11-16, under 510(k) number K013557.

Who is the listed applicant for LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW?

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 LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW?

The FDA product code for LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW is MBI.

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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: MBI)

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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