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FDA 510(k)

CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O

K-Number: K812401 · 1981-09-14

ApplicantSurgical Appliance Industries, Inc.
Decision Date1981-09-14
Product CodeIPT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O 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 1981-09-14 under 510(k) number K812401. The device is classified under product code IPT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O?

CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O is a medical device that received FDA 510(k) clearance on 1981-09-14. The listed applicant is Surgical Appliance Industries, Inc.. The 510(k) number is K812401.

When did CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O receive FDA 510(k) clearance?

CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O received FDA 510(k) clearance on 1981-09-14, under 510(k) number K812401.

Who is the listed applicant for CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O?

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 CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O?

The FDA product code for CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O is IPT.

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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 ORTHOSISK811689CYLINDER KNEE CAST/SPLINT

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Related Devices (Code: IPT)

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.

K963091VOLLMAN PRONE POSITIONERHill-Rom, Inc.K821645BACK SKPPORTSFred Sammons, Inc.K811750MULTITUBULAR THORACIC AIR SPLINTSRoger Cestac & Assoc.K761128LATERAL TRUNK SUPPORTSFred 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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