FDA 510(k)

PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1

K-Number: K082267 · 2008-10-29

Decision Date2008-10-29

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2008-10-29 under 510(k) number K082267. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1?

PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 is a medical device that received FDA 510(k) clearance on 2008-10-29. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K082267.

When did PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 receive FDA 510(k) clearance?

PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 received FDA 510(k) clearance on 2008-10-29, under 510(k) number K082267.

Who is the listed applicant for PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1?

The FDA product code for PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 is HAW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Smith & Nephew, Inc. as applicant

K261462LANDMARK Total Knee System K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

View all 509 devices →

Related Devices (Code: HAW)

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB K253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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.