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)

EXTERNAL ARTICULATION

K-Number: K781840 · 1978-11-08

ApplicantAce Orthopedic Manufacturing Co.
Decision Date1978-11-08
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXTERNAL ARTICULATION is the device name listed in this FDA 510(k) record. The listed applicant is Ace Orthopedic Manufacturing Co.. It received FDA 510(k) clearance on 1978-11-08 under 510(k) number K781840. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL ARTICULATION?

EXTERNAL ARTICULATION is a medical device that received FDA 510(k) clearance on 1978-11-08. The listed applicant is Ace Orthopedic Manufacturing Co.. The 510(k) number is K781840.

When did EXTERNAL ARTICULATION receive FDA 510(k) clearance?

EXTERNAL ARTICULATION received FDA 510(k) clearance on 1978-11-08, under 510(k) number K781840.

Who is the listed applicant for EXTERNAL ARTICULATION?

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

What is the FDA product code for EXTERNAL ARTICULATION?

The FDA product code for EXTERNAL ARTICULATION is JEC.

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 Orthopedic Manufacturing 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.

K934643ACE HUMERAL NAILK934962AIM SUPRACONDYLAR NAILK936045ACE UNILATERAL FIXATOR IIK926047ACE 8.0MM CANNULATED CANCELLOUS BONE SCREWK920738ACE 100 DEGREES TUBULAR PLATEK813554ACE/KYLE CAPTURED HIP SCREW

View all 14 devices →

Related Devices (Code: JEC)

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.

K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc.

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.

↑