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)

DEPUY ACE TIMAX META PLATE

K-Number: K983853 · 1998-12-22

ApplicantDepuy Ace Medical Co.
Decision Date1998-12-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY ACE TIMAX META PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ace Medical Co.. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K983853. 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 DEPUY ACE TIMAX META PLATE?

DEPUY ACE TIMAX META PLATE is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Depuy Ace Medical Co.. The 510(k) number is K983853.

When did DEPUY ACE TIMAX META PLATE receive FDA 510(k) clearance?

DEPUY ACE TIMAX META PLATE received FDA 510(k) clearance on 1998-12-22, under 510(k) number K983853.

Who is the listed applicant for DEPUY ACE TIMAX META PLATE?

The FDA 510(k) record lists Depuy Ace Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEPUY ACE TIMAX META PLATE?

The FDA product code for DEPUY ACE TIMAX META PLATE 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 Depuy Ace Medical Co. 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.

K990392DEPUY ACE SPIDER PLATEK990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATEK984458DEPUY ACE SPIDER PLATEK983265DEPUY ACE COMPOSITE LOCKING NUTK982347DEPUY ACE TIMAX PILON PLATEK981775DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE

View all 10 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.

↑