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FDA 510(k)

4CIS® Chiron Spinal Fixation System

K-Number: K231655 · 2024-11-26

ApplicantSolco Biomedical Co., Ltd.
Decision Date2024-11-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4CIS® Chiron Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K231655. 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 4CIS® Chiron Spinal Fixation System?

4CIS® Chiron Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K231655.

When did 4CIS® Chiron Spinal Fixation System receive FDA 510(k) clearance?

4CIS® Chiron Spinal Fixation System received FDA 510(k) clearance on 2024-11-26, under 510(k) number K231655.

Who is the listed applicant for 4CIS® Chiron Spinal Fixation System?

The FDA 510(k) record lists Solco Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS® Chiron Spinal Fixation System?

The FDA product code for 4CIS® Chiron Spinal Fixation System is NKB.

Other records listing Solco Biomedical Co., Ltd. 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.

K2032334CIS Chiron Spinal Fixation SystemK1920444CIS Marlin PEEK ACIF CageK1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF CageK1904714CIS® Chiron Spinal Fixation SystemK1824894CIS® Pinehurst Anterior Cervical Plate systemK1624024CIS® Marlin ACIF Cage System

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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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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