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FDA 510(k)

THE C-S DISTRACTION ROD ASSEMBLY

K-Number: K890187 · 1989-04-06

ApplicantOrthopedic Systems, Inc.
Decision Date1989-04-06
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE C-S DISTRACTION ROD ASSEMBLY 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 1989-04-06 under 510(k) number K890187. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE C-S DISTRACTION ROD ASSEMBLY?

THE C-S DISTRACTION ROD ASSEMBLY is a medical device that received FDA 510(k) clearance on 1989-04-06. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K890187.

When did THE C-S DISTRACTION ROD ASSEMBLY receive FDA 510(k) clearance?

THE C-S DISTRACTION ROD ASSEMBLY received FDA 510(k) clearance on 1989-04-06, under 510(k) number K890187.

Who is the listed applicant for THE C-S DISTRACTION ROD ASSEMBLY?

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 THE C-S DISTRACTION ROD ASSEMBLY?

The FDA product code for THE C-S DISTRACTION ROD ASSEMBLY is KWP.

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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: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, 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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