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FDA 510(k)

TRACTION-STEEL FRAMING SYSTEM

K-Number: K823395 · 1982-12-03

ApplicantOrthopedic Systems, Inc.
Decision Date1982-12-03
Product CodeHST
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRACTION-STEEL FRAMING SYSTEM 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 1982-12-03 under 510(k) number K823395. 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 TRACTION-STEEL FRAMING SYSTEM?

TRACTION-STEEL FRAMING SYSTEM is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K823395.

When did TRACTION-STEEL FRAMING SYSTEM receive FDA 510(k) clearance?

TRACTION-STEEL FRAMING SYSTEM received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823395.

Who is the listed applicant for TRACTION-STEEL FRAMING SYSTEM?

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 TRACTION-STEEL FRAMING SYSTEM?

The FDA product code for TRACTION-STEEL FRAMING SYSTEM is HST.

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Other records listing Orthopedic Systems, 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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Related Devices (Code: HST)

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.

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, DCK984190BACK-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.

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