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FDA 510(k)

SENTINEL SPINAL SYSTEM

K-Number: K090343 · 2009-08-11

ApplicantLife Spine
Decision Date2009-08-11
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SENTINEL SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine. It received FDA 510(k) clearance on 2009-08-11 under 510(k) number K090343. 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 SENTINEL SPINAL SYSTEM?

SENTINEL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-08-11. The listed applicant is Life Spine. The 510(k) number is K090343.

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

SENTINEL SPINAL SYSTEM received FDA 510(k) clearance on 2009-08-11, under 510(k) number K090343.

Who is the listed applicant for SENTINEL SPINAL SYSTEM?

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

What is the FDA product code for SENTINEL SPINAL SYSTEM?

The FDA product code for SENTINEL SPINAL SYSTEM is KWP.

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Other records listing Life Spine 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.

K182470Plateau Spacer SystemK160169The Life Spine Subtalar Implant SystemK131077LIFE SPINE PLATEAU SPACER SYSTEMK123373NAUTILUS SPINAL SYSTEMK120998SOLSTICE CROSS CONNECTORK111953NAUTILUS SPINAL 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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