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FDA 510(k)

ICON POLYAXIAL PEDICLE SCREW SYSTEM

K-Number: K033090 · 2004-03-26

ApplicantAlphatec Mfg., Inc.
Decision Date2004-03-26
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ICON POLYAXIAL PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Mfg., Inc.. It received FDA 510(k) clearance on 2004-03-26 under 510(k) number K033090. 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 ICON POLYAXIAL PEDICLE SCREW SYSTEM?

ICON POLYAXIAL PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-26. The listed applicant is Alphatec Mfg., Inc.. The 510(k) number is K033090.

When did ICON POLYAXIAL PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

ICON POLYAXIAL PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2004-03-26, under 510(k) number K033090.

Who is the listed applicant for ICON POLYAXIAL PEDICLE SCREW SYSTEM?

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

What is the FDA product code for ICON POLYAXIAL PEDICLE SCREW SYSTEM?

The FDA product code for ICON POLYAXIAL PEDICLE SCREW SYSTEM is KWP.

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Other records listing Alphatec Mfg., Inc. as applicant

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K023299ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEMK020356ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEMK993513DELTALOC ANTERIOR CERVICAL PLATE SYSTEMK993873ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION RODK992350PYLON INTRAMEDULLAARY NAIL SYSTEMK980788ALPHATEC WIRE EXTERNAL FIXATION 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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