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FDA 510(k)

Ripley Spinal Screw System by SAGICO

K-Number: K232561 · 2023-10-23

ApplicantSagico VA USA, LLC
Decision Date2023-10-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ripley Spinal Screw System by SAGICO is the device name listed in this FDA 510(k) record. The listed applicant is Sagico VA USA, LLC. It received FDA 510(k) clearance on 2023-10-23 under 510(k) number K232561. 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 Ripley Spinal Screw System by SAGICO?

Ripley Spinal Screw System by SAGICO is a medical device that received FDA 510(k) clearance on 2023-10-23. The listed applicant is Sagico VA USA, LLC. The 510(k) number is K232561.

When did Ripley Spinal Screw System by SAGICO receive FDA 510(k) clearance?

Ripley Spinal Screw System by SAGICO received FDA 510(k) clearance on 2023-10-23, under 510(k) number K232561.

Who is the listed applicant for Ripley Spinal Screw System by SAGICO?

The FDA 510(k) record lists Sagico VA USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ripley Spinal Screw System by SAGICO?

The FDA product code for Ripley Spinal Screw System by SAGICO is NKB.

Other records listing Sagico VA USA, LLC 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.

K221138Titus Titanium Cervical by SAGICOK223143SAGICO Spinal System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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