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 FIXATION

K-Number: K904973 · 1991-02-21

ApplicantDynasplint Systems, Inc.
Decision Date1991-02-21
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXTERNAL FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Dynasplint Systems, Inc.. It received FDA 510(k) clearance on 1991-02-21 under 510(k) number K904973. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL FIXATION?

EXTERNAL FIXATION is a medical device that received FDA 510(k) clearance on 1991-02-21. The listed applicant is Dynasplint Systems, Inc.. The 510(k) number is K904973.

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

EXTERNAL FIXATION received FDA 510(k) clearance on 1991-02-21, under 510(k) number K904973.

Who is the listed applicant for EXTERNAL FIXATION?

The FDA 510(k) record lists Dynasplint Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL FIXATION?

The FDA product code for EXTERNAL FIXATION is KTT.

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 Dynasplint Systems, 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.

K822767UNIVERSAL DYNASPLINT

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253202Hoffmann LRF SystemStryker GmbHK253613Monkey Rings External Ring Fixation SystemParagon 28, 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.

↑