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FDA 510(k)

SAGITTAL KNEE TESTER

K-Number: K831041 · 1983-06-24

ApplicantOrthopedic Systems, Inc.
Decision Date1983-06-24
Product CodeFTY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAGITTAL KNEE TESTER 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 1983-06-24 under 510(k) number K831041. The device is classified under product code FTY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAGITTAL KNEE TESTER?

SAGITTAL KNEE TESTER is a medical device that received FDA 510(k) clearance on 1983-06-24. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K831041.

When did SAGITTAL KNEE TESTER receive FDA 510(k) clearance?

SAGITTAL KNEE TESTER received FDA 510(k) clearance on 1983-06-24, under 510(k) number K831041.

Who is the listed applicant for SAGITTAL KNEE TESTER?

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 SAGITTAL KNEE TESTER?

The FDA product code for SAGITTAL KNEE TESTER is FTY.

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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: FTY)

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.

K160501Noxilizer Surgical RulerNoxilizer, Inc.K951064DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTICS-E Sales & Distribution, Inc.K934930OLYMPIC AUTO-LENGTHOlympic Medical Corp.K932112OLYMPIC INFA-LENGTHOlympic Medical Corp.K883485STRYKER PRESSURE MONITOR SYSTEMStryker Corp.K880441PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.Plane Iii, 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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