Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ProMIS™ Fixation System

K-Number: K170061 · 2017-02-02

ApplicantPremia Spine, Ltd.
Decision Date2017-02-02
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ProMIS™ Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Premia Spine, Ltd.. It received FDA 510(k) clearance on 2017-02-02 under 510(k) number K170061. 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 ProMIS™ Fixation System?

ProMIS™ Fixation System is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is Premia Spine, Ltd.. The 510(k) number is K170061.

When did ProMIS™ Fixation System receive FDA 510(k) clearance?

ProMIS™ Fixation System received FDA 510(k) clearance on 2017-02-02, under 510(k) number K170061.

Who is the listed applicant for ProMIS™ Fixation System?

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

What is the FDA product code for ProMIS™ Fixation System?

The FDA product code for ProMIS™ Fixation System is NKB.

Other records listing Premia Spine, Ltd. 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.

PMA P220002Prosthesis, posterior spinal elementsK232719ProMIS Extension Rod SystemK231844ProMIS™ Fixation SystemK191854Premia Spine XL InstrumentsK182598VersaLink™ Fixation 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

View on FDA Database →

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

↑