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FDA 510(k)

CYLINDER KNEE CAST/SPLINT

K-Number: K811689 · 1981-06-25

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

Device Summary

CYLINDER KNEE 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 K811689. The device is classified under product code ITQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYLINDER KNEE CAST/SPLINT?

CYLINDER KNEE 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 K811689.

When did CYLINDER KNEE CAST/SPLINT receive FDA 510(k) clearance?

CYLINDER KNEE CAST/SPLINT received FDA 510(k) clearance on 1981-06-25, under 510(k) number K811689.

Who is the listed applicant for CYLINDER KNEE 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 CYLINDER KNEE CAST/SPLINT?

The FDA product code for CYLINDER KNEE CAST/SPLINT is ITQ.

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Other records listing Surgical Appliance Industries, 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.

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: ITQ)

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.

K831044LIMITED MOTION FUNCTIONAL KNEE BRACEOrthopedic Systems, Inc.K831310BRACE C.T.Innovation Sports, Inc.K823658DELUXE KNEE IMMOBILIZER(UNIVERSAL)Warm & Form, Orthopedic MaterialsK823397ANATOMIC FRACTURE BRACEOrthopedic Systems, Inc.K823159DELUXE KNEE IMMOBILIZERWarm & Form, Orthopedic MaterialsK812423NEOPRENE KNEE SUPPORTSurgical Appliance Industries, 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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