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)

ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS

K-Number: K885250 · 1989-02-13

ApplicantHowmedica Corp.
Decision Date1989-02-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1989-02-13 under 510(k) number K885250. 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 ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS?

ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS is a medical device that received FDA 510(k) clearance on 1989-02-13. The listed applicant is Howmedica Corp.. The 510(k) number is K885250.

When did ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS receive FDA 510(k) clearance?

ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS received FDA 510(k) clearance on 1989-02-13, under 510(k) number K885250.

Who is the listed applicant for ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS?

The FDA product code for ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS 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 Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

View all 373 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.

↑