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FDA 510(k)

ISOLA POLYAXIAL WASHER

K-Number: K013441 · 2001-11-16

ApplicantDepuyacromed
Decision Date2001-11-16
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISOLA POLYAXIAL WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Depuyacromed. It received FDA 510(k) clearance on 2001-11-16 under 510(k) number K013441. 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 ISOLA POLYAXIAL WASHER?

ISOLA POLYAXIAL WASHER is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Depuyacromed. The 510(k) number is K013441.

When did ISOLA POLYAXIAL WASHER receive FDA 510(k) clearance?

ISOLA POLYAXIAL WASHER received FDA 510(k) clearance on 2001-11-16, under 510(k) number K013441.

Who is the listed applicant for ISOLA POLYAXIAL WASHER?

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

What is the FDA product code for ISOLA POLYAXIAL WASHER?

The FDA product code for ISOLA POLYAXIAL WASHER is KWP.

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Other records listing Depuyacromed 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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