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FDA 510(k)

OsseoScrew System

K-Number: K181980 · 2018-09-25

ApplicantAlphatec Spine, Inc.
Decision Date2018-09-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsseoScrew System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2018-09-25 under 510(k) number K181980. 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 OsseoScrew System?

OsseoScrew System is a medical device that received FDA 510(k) clearance on 2018-09-25. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K181980.

When did OsseoScrew System receive FDA 510(k) clearance?

OsseoScrew System received FDA 510(k) clearance on 2018-09-25, under 510(k) number K181980.

Who is the listed applicant for OsseoScrew System?

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

What is the FDA product code for OsseoScrew System?

The FDA product code for OsseoScrew System is NKB.

Other records listing Alphatec Spine, 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.

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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