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FDA 510(k)

ROMEO® 2 Posterior Osteosynthesis System

K-Number: K172101 · 2017-09-26

ApplicantSpineart
Decision Date2017-09-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROMEO® 2 Posterior Osteosynthesis System is the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2017-09-26 under 510(k) number K172101. 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 ROMEO® 2 Posterior Osteosynthesis System?

ROMEO® 2 Posterior Osteosynthesis System is a medical device that received FDA 510(k) clearance on 2017-09-26. The listed applicant is Spineart. The 510(k) number is K172101.

When did ROMEO® 2 Posterior Osteosynthesis System receive FDA 510(k) clearance?

ROMEO® 2 Posterior Osteosynthesis System received FDA 510(k) clearance on 2017-09-26, under 510(k) number K172101.

Who is the listed applicant for ROMEO® 2 Posterior Osteosynthesis System?

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

What is the FDA product code for ROMEO® 2 Posterior Osteosynthesis System?

The FDA product code for ROMEO® 2 Posterior Osteosynthesis System is NKB.

Other records listing Spineart 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.

K262639BAGUERA® C Cervical Disc Surgical InstrumentsK261205SPINEART Navigation Instrument SystemK253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemK254158SPINEART Navigation Instrument SystemK242933SPINEART Navigation Instrument SystemK242890SPINEART Navigation Instrument 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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