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FDA 510(k)

CASPIAN

K-Number: K113654 · 2012-01-12

ApplicantK2m, Inc.
Decision Date2012-01-12
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CASPIAN is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2012-01-12 under 510(k) number K113654. 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?

CASPIAN is a medical device that received FDA 510(k) clearance on 2012-01-12. The listed applicant is K2m, Inc.. The 510(k) number is K113654.

When did CASPIAN receive FDA 510(k) clearance?

CASPIAN received FDA 510(k) clearance on 2012-01-12, under 510(k) number K113654.

Who is the listed applicant for CASPIAN?

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?

The FDA product code for CASPIAN 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

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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