FDA 510(k)

Smith+Nephew INTELLIO Tablet

K-Number: K221929 · 2022-09-06

Decision Date2022-09-06

Product CodeODA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Smith+Nephew INTELLIO Tablet is the device name listed in this FDA 510(k) record. The listed applicant is Smith+Nephew. It received FDA 510(k) clearance on 2022-09-06 under 510(k) number K221929. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smith+Nephew INTELLIO Tablet?

Smith+Nephew INTELLIO Tablet is a medical device that received FDA 510(k) clearance on 2022-09-06. The listed applicant is Smith+Nephew. The 510(k) number is K221929.

When did Smith+Nephew INTELLIO Tablet receive FDA 510(k) clearance?

Smith+Nephew INTELLIO Tablet received FDA 510(k) clearance on 2022-09-06, under 510(k) number K221929.

Who is the listed applicant for Smith+Nephew INTELLIO Tablet?

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

What is the FDA product code for Smith+Nephew INTELLIO Tablet?

The FDA product code for Smith+Nephew INTELLIO Tablet is ODA.

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Other records listing Smith+Nephew as applicant

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 PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis 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)

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Related Devices (Code: ODA)

K232406KARL STORZ OR1™ SCB CONTROL (WU300)Karl Storz SE & CO. KG K203566Tablet ApplicationSmith & Nephew K192876INTELLIO Tablet ApplicationSmith & Nephew K153205IDSS ForceTriad Control ModuleBlack Diamond Video, Inc.K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp.

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.