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FDA 510(k)

ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION

K-Number: K001535 · 2001-03-20

ApplicantOrtho Tec, LLC
Decision Date2001-03-20
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION 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 2001-03-20 under 510(k) number K001535. 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 ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION?

ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 2001-03-20. The listed applicant is Ortho Tec, LLC. The 510(k) number is K001535.

When did ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION receive FDA 510(k) clearance?

ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION received FDA 510(k) clearance on 2001-03-20, under 510(k) number K001535.

Who is the listed applicant for ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION?

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 ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION?

The FDA product code for ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION 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.

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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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