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FDA 510(k)

CASPIAN SPINAL SYSTEM

K-Number: K103232 · 2011-01-13

ApplicantK2m, Inc.
Decision Date2011-01-13
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CASPIAN SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2011-01-13 under 510(k) number K103232. 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 CASPIAN SPINAL SYSTEM?

CASPIAN SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-13. The listed applicant is K2m, Inc.. The 510(k) number is K103232.

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

CASPIAN SPINAL SYSTEM received FDA 510(k) clearance on 2011-01-13, under 510(k) number K103232.

Who is the listed applicant for CASPIAN SPINAL SYSTEM?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CASPIAN SPINAL SYSTEM?

The FDA product code for CASPIAN SPINAL SYSTEM is KWP.

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Other records listing K2m, Inc. as applicant

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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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