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FDA 510(k)

CTI II STRAIGHT STEM

K-Number: K891539 · 1989-06-08

ApplicantOrthopedic Systems, Inc.
Decision Date1989-06-08
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CTI II STRAIGHT STEM 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 1989-06-08 under 510(k) number K891539. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CTI II STRAIGHT STEM?

CTI II STRAIGHT STEM is a medical device that received FDA 510(k) clearance on 1989-06-08. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K891539.

When did CTI II STRAIGHT STEM receive FDA 510(k) clearance?

CTI II STRAIGHT STEM received FDA 510(k) clearance on 1989-06-08, under 510(k) number K891539.

Who is the listed applicant for CTI II STRAIGHT STEM?

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 CTI II STRAIGHT STEM?

The FDA product code for CTI II STRAIGHT STEM is LWJ.

Related Clinical Trials

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.

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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: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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