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FDA 510(k)

SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM

K-Number: K030087 · 2003-07-17

ApplicantSpinal Concepts, Inc.
Decision Date2003-07-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL CONCEPTS, INC. BACFIX TI SPINAL 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 2003-07-17 under 510(k) number K030087. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM?

SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-07-17. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K030087.

When did SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM receive FDA 510(k) clearance?

SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM received FDA 510(k) clearance on 2003-07-17, under 510(k) number K030087.

Who is the listed applicant for SPINAL CONCEPTS, INC. BACFIX TI SPINAL 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. BACFIX TI SPINAL SYSTEM?

The FDA product code for SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM is NKB.

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Other records listing Spinal Concepts, Inc. as applicant

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Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253943Tiger 2 SystemZavation Medical Products, LLC

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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