FDA 510(k)

UPPER EXTREMITY TRACTION DEVICE

K-Number: K803021 · 1980-12-12

Decision Date1980-12-12

Product CodeHST

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

UPPER EXTREMITY TRACTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1980-12-12 under 510(k) number K803021. The device is classified under product code HST. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UPPER EXTREMITY TRACTION DEVICE?

UPPER EXTREMITY TRACTION DEVICE is a medical device that received FDA 510(k) clearance on 1980-12-12. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K803021.

When did UPPER EXTREMITY TRACTION DEVICE receive FDA 510(k) clearance?

UPPER EXTREMITY TRACTION DEVICE received FDA 510(k) clearance on 1980-12-12, under 510(k) number K803021.

Who is the listed applicant for UPPER EXTREMITY TRACTION DEVICE?

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

What is the FDA product code for UPPER EXTREMITY TRACTION DEVICE?

The FDA product code for UPPER EXTREMITY TRACTION DEVICE is HST.

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Other records listing Orthopedic Systems, Inc. as applicant

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Related Devices (Code: HST)

K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression TableStl International, Inc.K110858LO-BAK TRAXRoland F Berthiaume, DC K984190BACK-ON-TRAC, MODEL 101BOTBack-On-Track, Inc.K872121K AND D HOME TRACTJoseph A. Kott, M.D.K870212ARTHROSCOPIC SHOULDER HOLDERDyonics, Inc.K870125EXTREMITY ELEVATOROrthopedic Systems, 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.