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FDA 510(k)

SCS SPINAL SYSTEM

K-Number: K983353 · 1998-12-18

ApplicantOrthotec, Inc.
Decision Date1998-12-18
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCS SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthotec, Inc.. It received FDA 510(k) clearance on 1998-12-18 under 510(k) number K983353. 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 SCS SPINAL SYSTEM?

SCS SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-18. The listed applicant is Orthotec, Inc.. The 510(k) number is K983353.

When did SCS SPINAL SYSTEM receive FDA 510(k) clearance?

SCS SPINAL SYSTEM received FDA 510(k) clearance on 1998-12-18, under 510(k) number K983353.

Who is the listed applicant for SCS SPINAL SYSTEM?

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

What is the FDA product code for SCS SPINAL SYSTEM?

The FDA product code for SCS SPINAL SYSTEM is KWP.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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