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FDA 510(k)

CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS

K-Number: K812422 · 1981-09-14

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

Device Summary

CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS 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 K812422. The device is classified under product code IPY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS?

CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS 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 K812422.

When did CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS receive FDA 510(k) clearance?

CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS received FDA 510(k) clearance on 1981-09-14, under 510(k) number K812422.

Who is the listed applicant for CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS?

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 CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS?

The FDA product code for CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS is IPY.

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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 SUPPORTK812401CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. OK811689CYLINDER KNEE CAST/SPLINT

View all 9 devices →

Related Devices (Code: IPY)

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.

K823882M-BRACEBuckman ConsultantsK823823LUMBOSACRAL SUPPORTDanek Medical, Inc.K812099CASH ORTHOSISDavid Hendricks, C.P.O.K811494LUMBO-SACRAL FLEXION ORTHOSISSurgical Appliance Industries, Inc.K810554LUMBAR FLEXION BRACEOrthomedicsK810556SPINAL EXTENSION BRACEOrthomedics

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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