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FDA 510(k)

SAGICO OSI Spinal System by Osimplant

K-Number: K180220 · 2018-05-21

ApplicantSpinal Analytics & Geometrical Implant Co, LLC
Decision Date2018-05-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SAGICO OSI Spinal System by Osimplant is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Analytics & Geometrical Implant Co, LLC. It received FDA 510(k) clearance on 2018-05-21 under 510(k) number K180220. 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 SAGICO OSI Spinal System by Osimplant?

SAGICO OSI Spinal System by Osimplant is a medical device that received FDA 510(k) clearance on 2018-05-21. The listed applicant is Spinal Analytics & Geometrical Implant Co, LLC. The 510(k) number is K180220.

When did SAGICO OSI Spinal System by Osimplant receive FDA 510(k) clearance?

SAGICO OSI Spinal System by Osimplant received FDA 510(k) clearance on 2018-05-21, under 510(k) number K180220.

Who is the listed applicant for SAGICO OSI Spinal System by Osimplant?

The FDA 510(k) record lists Spinal Analytics & Geometrical Implant Co, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAGICO OSI Spinal System by Osimplant?

The FDA product code for SAGICO OSI Spinal System by Osimplant is NKB.

Other records listing Spinal Analytics & Geometrical Implant Co, 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.

K233191TotalTi ACDF by SAGICO

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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