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FDA 510(k)

CENTRA-LINE GRAPPLE, VARIFIX SYSTEM

K-Number: K954770 · 1996-01-25

ApplicantAdvanced Spine Fixation Systems, Inc.
Decision Date1996-01-25
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CENTRA-LINE GRAPPLE, VARIFIX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Spine Fixation Systems, Inc.. It received FDA 510(k) clearance on 1996-01-25 under 510(k) number K954770. 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 CENTRA-LINE GRAPPLE, VARIFIX SYSTEM?

CENTRA-LINE GRAPPLE, VARIFIX SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-25. The listed applicant is Advanced Spine Fixation Systems, Inc.. The 510(k) number is K954770.

When did CENTRA-LINE GRAPPLE, VARIFIX SYSTEM receive FDA 510(k) clearance?

CENTRA-LINE GRAPPLE, VARIFIX SYSTEM received FDA 510(k) clearance on 1996-01-25, under 510(k) number K954770.

Who is the listed applicant for CENTRA-LINE GRAPPLE, VARIFIX SYSTEM?

The FDA 510(k) record lists Advanced Spine Fixation Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRA-LINE GRAPPLE, VARIFIX SYSTEM?

The FDA product code for CENTRA-LINE GRAPPLE, VARIFIX SYSTEM is KWP.

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Other records listing Advanced Spine Fixation Systems, Inc. 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.

K992012WILTSE SYSTEMK990845MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15K953779SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEMK953778SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEMK953369STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREWK9513085.8MM DIAMETER ANCHOR SCREW

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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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