FDA 510(k)

TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW

K-Number: K981529 · 1998-07-09

Decision Date1998-07-09

Product CodeJDS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW 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 1998-07-09 under 510(k) number K981529. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW?

TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K981529.

When did TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW receive FDA 510(k) clearance?

TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW received FDA 510(k) clearance on 1998-07-09, under 510(k) number K981529.

Who is the listed applicant for TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW?

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 TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW?

The FDA product code for TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW is JDS.

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: JDS)

K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC

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.