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FDA 510(k)

STERISPINEPS PEDICLE SCREW

K-Number: K112453 · 2011-11-15

ApplicantSafe Orthopaedics
Decision Date2011-11-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STERISPINEPS PEDICLE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Safe Orthopaedics. It received FDA 510(k) clearance on 2011-11-15 under 510(k) number K112453. 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 STERISPINEPS PEDICLE SCREW?

STERISPINEPS PEDICLE SCREW is a medical device that received FDA 510(k) clearance on 2011-11-15. The listed applicant is Safe Orthopaedics. The 510(k) number is K112453.

When did STERISPINEPS PEDICLE SCREW receive FDA 510(k) clearance?

STERISPINEPS PEDICLE SCREW received FDA 510(k) clearance on 2011-11-15, under 510(k) number K112453.

Who is the listed applicant for STERISPINEPS PEDICLE SCREW?

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 STERISPINEPS PEDICLE SCREW?

The FDA product code for STERISPINEPS PEDICLE SCREW is NKB.

Related Clinical Trials

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.

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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.

K201648Sterispine™ PSK170528Sterispine™ PSK162531STERISPINE CCK130632STERISPINE PS PEDICLE SCREWK122021STERISPINE LC CAGEK121299STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD

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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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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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