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FDA 510(k)

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

K-Number: K042673 · 2004-10-27

ApplicantAlphatec/Nexmed
Decision Date2004-10-27
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec/Nexmed. It received FDA 510(k) clearance on 2004-10-27 under 510(k) number K042673. 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 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM?

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-27. The listed applicant is Alphatec/Nexmed. The 510(k) number is K042673.

When did ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2004-10-27, under 510(k) number K042673.

Who is the listed applicant for ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM?

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

What is the FDA product code for ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM?

The FDA product code for ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM is KWP.

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Other records listing Alphatec/Nexmed 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.

K050830ZODIAC SPINAL FIXATION SYSTEMK051286ZODIAC SPINAL FIXATION SYSTEMK050553NOVEL VBR SPINAL SYSTEMK050390TAMARACK ANTERIOR THORACOLUNBARK050078ROC LUMBAR PLATING SYSTEMK042252NEXFLEX TOTAL HIP SYSTEM

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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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