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FDA 510(k)

UNIVERSAL DYNASPLINT

K-Number: K822767 · 1982-10-06

ApplicantDynasplint Systems, Inc.
Decision Date1982-10-06
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL DYNASPLINT 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 1982-10-06 under 510(k) number K822767. The device is classified under product code IQI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL DYNASPLINT?

UNIVERSAL DYNASPLINT is a medical device that received FDA 510(k) clearance on 1982-10-06. The listed applicant is Dynasplint Systems, Inc.. The 510(k) number is K822767.

When did UNIVERSAL DYNASPLINT receive FDA 510(k) clearance?

UNIVERSAL DYNASPLINT received FDA 510(k) clearance on 1982-10-06, under 510(k) number K822767.

Who is the listed applicant for UNIVERSAL DYNASPLINT?

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 UNIVERSAL DYNASPLINT?

The FDA product code for UNIVERSAL DYNASPLINT is IQI.

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.

K904973EXTERNAL FIXATION

Related Devices (Code: IQI)

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.

K052771SENSOR WALKOtto Bock Healthcare LPK031576SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1Surgitech, Inc.K926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.K910974MCCONNELL SHOULDER BRACEMcconnell OrthopedicK874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEFred Sammons, 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.

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