Spinal FrontiersPowered by NSpineWeekly alert sign-up
← Back

Spinal Frontiers · Regulatory Watch · FDA decision

Spineart's PERLA TL screws cleared for robot-assisted placement on Op.n

FDA decision · Spineart / eCential Robotics

28 August 2026

The two companies announced 510(k) clearance of the PERLA TL application, which lets PERLA TL open and MIS pedicle screws be placed using eCential's Op.n navigation and robotic-assistance platform. FDA's database shows the clearance was granted on 29 July, a month before the announcement.

Type
FDA decision
Company
Spineart / eCential Robotics
Device
PERLA TL app for the eCential Op.n navigation and robotic platform
Date
28 August 2026
Jurisdiction
US
Classification
510(k) K261205 (OLO; FDA decision 29 July 2026, announced 28 August)
Source
BioAlps (company announcement)

Official source →Source checked

More from Regulatory Watch on Spineart / eCential Robotics

Other FDA decisions

← All of Regulatory Watch

Clinical PracticeLiterature WatchPatent WatchBooksGuideline LibraryCase of the MonthGuest EditorRare DiseasesReport a Device ProblemSafety in FocusSecure MessagingViewing Scans (DICOM)Measurement AppsCoding & ReimbursementVeterinary SpineSpine PodcastsGet Involved
Training & CareersTrainee HubFellowshipsJobsGet InvolvedSpine Podcasts
ResearchTrials WatchSpine RegistriesSpine JournalsFunding CallsSpine Podcasts
Medtech & InnovationIndustry RoundupProduct DevelopmentsRegulatory WatchImplant SystemsHow It's MadeAI & Emerging TechOff Duty: Podcasts for RepsSpine Theatre BuilderSpine MarketsCoding & Reimbursement
Meetings & SocietiesConferences & CoursesAbstract DeadlinesSpine Societies Worldwide
Spine Team & Allied HealthFor the Spine TeamSpine AnaesthesiaNeuromonitoringPain MedicineTheatre SafetyHalo TractionSpine PodcastsGet Involved
WellbeingHealth & NutritionBody & MindSupplementsMental Health for Clinicians
About & editorial policyFeedbackWeekly alert sign-upBack issuesPrivacy noticeDon't count my visitsLegal noticeCorrections for companiesAdvertise with usPartner OffersSearchUse as an app

Spinal Frontiers is published by NSpine Limited, registered in England and Wales (company no. 08362634), 14 Park Row, Nottingham NG1 6GR, United Kingdom. Every item is summarised in our own words and links to its original source. Listings are a selection made at NSpine's editorial discretion and are not exhaustive; inclusion is not an endorsement, and omission implies nothing. Sponsors and advertisers have no influence on what we cover. Nothing here is medical, legal or financial advice. Spotted an error or a broken link? Email spinalfrontiers@nspine.com, or use the feedback page.

Spinal Frontiers is a trademark of NSpine GmbH.

Information only, summarised from third-party sources: not medical, legal, regulatory or financial advice. Full disclaimer.

© 2013 – 2026 NSpine Limited. Privacy notice.