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FDA 510(k)

PERLA® TL System; TEKTONA® HV US Bone Cement

K-Number: K230774 · 2023-06-23

ApplicantSpineart
Decision Date2023-06-23
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERLA® TL System; TEKTONA® HV US Bone Cement is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2023-06-23 under approval number K230774. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERLA® TL System; TEKTONA® HV US Bone Cement?

PERLA® TL System; TEKTONA® HV US Bone Cement is a medical device that received FDA 510(k) clearance on 2023-06-23. It is manufactured by Spineart. The 510(k) number is K230774.

When was PERLA® TL System; TEKTONA® HV US Bone Cement approved by the FDA?

PERLA® TL System; TEKTONA® HV US Bone Cement received FDA 510(k) clearance on 2023-06-23, under approval number K230774.

What company makes PERLA® TL System; TEKTONA® HV US Bone Cement?

PERLA® TL System; TEKTONA® HV US Bone Cement is manufactured by Spineart.

What is the FDA product code for PERLA® TL System; TEKTONA® HV US Bone Cement?

The FDA product code for PERLA® TL System; TEKTONA® HV US Bone Cement is PML.

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Related Devices (Code: PML)

K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc. K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , 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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