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)

ACE RECONSTRUCTIVE PLATE

K-Number: K905595 · 1991-03-14

ApplicantAce Medical Co.
Decision Date1991-03-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE RECONSTRUCTIVE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Co.. It received FDA 510(k) clearance on 1991-03-14 under 510(k) number K905595. 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 ACE RECONSTRUCTIVE PLATE?

ACE RECONSTRUCTIVE PLATE is a medical device that received FDA 510(k) clearance on 1991-03-14. The listed applicant is Ace Medical Co.. The 510(k) number is K905595.

When did ACE RECONSTRUCTIVE PLATE receive FDA 510(k) clearance?

ACE RECONSTRUCTIVE PLATE received FDA 510(k) clearance on 1991-03-14, under 510(k) number K905595.

Who is the listed applicant for ACE RECONSTRUCTIVE PLATE?

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

What is the FDA product code for ACE RECONSTRUCTIVE PLATE?

The FDA product code for ACE RECONSTRUCTIVE 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 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.

K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILK955472ACE HUMERUS & RADIUS PLATESK955388ACE-DUPONT COMPOSITE RINGSK9544856.5MM SOLID CANCELLOUS BONE SCREWK954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSK950618ACE SUPRACONDYLAR PLATE

View all 21 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.

↑