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FDA 510(k)

OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY

K-Number: K984375 · 1999-04-30

ApplicantOsteonics Corp.
Decision Date1999-04-30
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1999-04-30 under 510(k) number K984375. 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 OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY?

OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY is a medical device that received FDA 510(k) clearance on 1999-04-30. The listed applicant is Osteonics Corp.. The 510(k) number is K984375.

When did OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY receive FDA 510(k) clearance?

OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY received FDA 510(k) clearance on 1999-04-30, under 510(k) number K984375.

Who is the listed applicant for OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY?

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

What is the FDA product code for OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY?

The FDA product code for OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY is KWP.

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Other records listing Osteonics Corp. 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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