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FDA 510(k)

ANKLE-FOOT CAST/SPLINT

K-Number: K811690 · 1981-06-25

ApplicantSurgical Appliance Industries, Inc.
Decision Date1981-06-25
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ANKLE-FOOT CAST/SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Appliance Industries, Inc.. It received FDA 510(k) clearance on 1981-06-25 under 510(k) number K811690. 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 ANKLE-FOOT CAST/SPLINT?

ANKLE-FOOT CAST/SPLINT is a medical device that received FDA 510(k) clearance on 1981-06-25. The listed applicant is Surgical Appliance Industries, Inc.. The 510(k) number is K811690.

When did ANKLE-FOOT CAST/SPLINT receive FDA 510(k) clearance?

ANKLE-FOOT CAST/SPLINT received FDA 510(k) clearance on 1981-06-25, under 510(k) number K811690.

Who is the listed applicant for ANKLE-FOOT CAST/SPLINT?

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

What is the FDA product code for ANKLE-FOOT CAST/SPLINT?

The FDA product code for ANKLE-FOOT CAST/SPLINT is IQI.

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Other records listing Surgical Appliance Industries, Inc. as applicant

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K121106TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLETK821682TRUNCAL ORTHOSISK813416EXTERNAL BREAST PROSTHESISK812423NEOPRENE KNEE SUPPORTK812422CUSTOM CONTOUR LUMBOSACRAL ORTHOSISK812401CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O

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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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