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FDA 510(k)

Sterispine™ PS

K-Number: K201648 · 2020-07-30

ApplicantSafe Orthopaedics
Decision Date2020-07-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sterispine™ PS is the device name listed in this FDA 510(k) record. The listed applicant is Safe Orthopaedics. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K201648. 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 Sterispine™ PS?

Sterispine™ PS is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Safe Orthopaedics. The 510(k) number is K201648.

When did Sterispine™ PS receive FDA 510(k) clearance?

Sterispine™ PS received FDA 510(k) clearance on 2020-07-30, under 510(k) number K201648.

Who is the listed applicant for Sterispine™ PS?

The FDA 510(k) record lists Safe Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterispine™ PS?

The FDA product code for Sterispine™ PS is NKB.

Other records listing Safe Orthopaedics 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.

K170528Sterispine™ PSK162531STERISPINE CC

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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