Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW

K-Number: K011076 · 2001-07-16

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2001-07-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR 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 2001-07-16 under 510(k) number K011076. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW?

LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW is a medical device that received FDA 510(k) clearance on 2001-07-16. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K011076.

When did LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW receive FDA 510(k) clearance?

LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW received FDA 510(k) clearance on 2001-07-16, under 510(k) number K011076.

Who is the listed applicant for LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR 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 LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW?

The FDA product code for LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW is HRS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 56 devices →

Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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.

↑