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FDA 510(k)

SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM

K-Number: K042508 · 2004-10-07

ApplicantDepuy Spine, Inc.
Decision Date2004-10-07
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K042508. 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 SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM?

SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K042508.

When did SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM receive FDA 510(k) clearance?

SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042508.

Who is the listed applicant for SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM?

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

What is the FDA product code for SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM?

The FDA product code for SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM is KWP.

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Other records listing Depuy Spine, 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.

K201831CONFIDENCE Spinal Cement SystemK111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMK121020VIPER SYSTEMK110353MOUNTAINEER OCT SPINAL SYSTEMK110216EXPEDIUM SYSTEM, VIPER SYSTEMK103133VEPER SYSTEM, EXPEDIUM SYSTEM

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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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