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FDA 510(k)

ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03

K-Number: K031452 · 2003-06-18

ApplicantOrtho Tec, LLC
Decision Date2003-06-18
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Tec, LLC. It received FDA 510(k) clearance on 2003-06-18 under 510(k) number K031452. 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 ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03?

ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 is a medical device that received FDA 510(k) clearance on 2003-06-18. The listed applicant is Ortho Tec, LLC. The 510(k) number is K031452.

When did ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 receive FDA 510(k) clearance?

ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 received FDA 510(k) clearance on 2003-06-18, under 510(k) number K031452.

Who is the listed applicant for ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03?

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

What is the FDA product code for ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03?

The FDA product code for ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 is KWP.

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Other records listing Ortho Tec, LLC 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.

K040514EOVIA CALCIUM PHOSPHATE CERAMICK040346MODIFICATION TO ORIA TOP CLIP SYSTEMK030958ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORSK031471ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01K023884MODIFICATION ORIA SPINAL SYSTEMK023378ORIA CLARIS

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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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