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FDA 510(k)

SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM

K-Number: K040096 · 2004-07-01

ApplicantSpinal Concepts, Inc.
Decision Date2004-07-01
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Concepts, Inc.. It received FDA 510(k) clearance on 2004-07-01 under 510(k) number K040096. 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 SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM?

SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-01. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K040096.

When did SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM receive FDA 510(k) clearance?

SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM received FDA 510(k) clearance on 2004-07-01, under 510(k) number K040096.

Who is the listed applicant for SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM?

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

What is the FDA product code for SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM?

The FDA product code for SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM is KWP.

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Other records listing Spinal Concepts, 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.

K051000FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICEK050706HARMONY PORT SYSTEM, MODEL 1907 SERIESK033663SPINAL CONCEPTS INC. CODAK033517SPINAL CONCEPTS INC. CADENCE AND TRAXISK031855SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEMK031985SPINAL CONCEPTS INC. NEX-LINK SPINAL 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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