AC DEVICE - Lockdown AO Cortical Tap 3.5mm diameter (Sterile)
2017-02-23
LOCKDOWN MEDICAL LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8020712 | 3008237817 | LOCKDOWN MEDICAL LIMITED | 1 | N | 2026-01-01 | 16 The Oaks Clews Road Redditch Worcestershire GB B98 7ST |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 9695 | 1185345281 | K091207 | SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE | HTN | 2011-02-15 |
| 9695 | 1582943163 | K080447 | SURGICRAFT SCREW FIXATION SYSTEM | MBI | 2008-06-13 |
| 9695 | 1678379522 | K072370 | SURGICRAFT SURGICAL MESH SYSTEM | FTL | 2008-07-24 |
| 9695 | 1591853000 | ||||
| 9695 | 1432598896 | ||||
| 9695 | 1475556760 | ||||
| 9695 | 1546894362 | ||||
| 9695 | 1565243943 | ||||
| 9695 | 1772203944 | ||||
| 9695 | 1861408728 |
Product Codes Associated With Registrations#
GUDID#
LSSS - LOCKDOWN (LSSS) SURGICAL TRAY BASE WHICH HOUSES ALL INSTRUMENTS REQUIRED FOR THE LOCKDOWN SHOULDER STABILISATION PROCEDURE. tHIS TRAY ALSO HAS A LID (DI NO#: 05060433600920) ASSOCIATED WITH IT THAT LOCKS INTO PLACE. TRAY BASE SUPPLIED BY RUDISCHHAUSER.
2020-07-24
LSSS - Lockdown (LSSS) Surgical Instrument Metal Tray Lid. This Tray lid attaches to the Lockdown Tray base (DI NO#: 05060433600845). This lid is supplied by Rudischhauser.
2020-07-24
AC DEVICE - Lockdown 5cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 6cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 7cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 8cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 9cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 10cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 11cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 12cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 13cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 14cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 15cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 16cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 17cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 18cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 19cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - Lockdown 20cm Acromiaclavicular (AC) Device
2015-10-30
AC DEVICE - 9mm Washer
2015-10-30
AC DEVICE - LockDown Acromioclavicular (AC) Length Gauge
2017-02-23
LSSS - "AO SCREWDRIVER SHAFT Ø2.5MM (HEX). THE FINISHED PART NUMBER IS IN629/1 - ""AO SCREWDRIVER SHAFT Ø2.5MM (HEX) - RM04051"""
2020-07-24
LSSS - "DRILL SLEEVE Ø2.5mm & TAP SLEEVE Ø3.5mm. THE FINISHED PART NUMBER IS IN631/1 - ""DRILL SLEEVE Ø2.5mm & TAP SLEEVE Ø3.5mm - RM04053"""
2020-07-24
LSSS - "AO CANNULATED SILICONE SCREWDRIVER HANDLE WITH QUICK COUPLING. THE ""AO SCREWDRIVER SPINNER"" - DI NO# (05060433600883) SCREWS ONTO THE END OF THIS DEVICE. THIS CREATES THE FINAL INSTRUMENT IN630/1 - ""AO CANNULATED HANDLE WITH QUICK COUPLING AND SPINNER - AS01068"" "
2020-07-24
LSSS - "AO SCREWDRIVER SPINNER (THIS PART FITS ONTO THE BOTTOM END OF ""AO CANULATED SILICONE SCREWDRIVER HANDLE WITH QUICK COUPLING, RM06006 - PRIMARY DI NO# (0506433600876)"". THIS INSTRUMENT PART ALONG WITH ""AO CANULATED SILICONE SCREWDRIVER HANDLE WITH QUICK COUPLING"" MAKEUP INSTRUMENT IN630/1 - ""AO CANNULATED HANDLE WITH QUICK COUPLING AND SPINNER - AS01068"" "
2020-07-24
LSSS - "DEPTH GAUGE OUTER BODY CAP. THIS CAP SCREWS ONTO ""DEPTH GAUGE OUTER BODY TUBE - RM06008 (DI NO# 05060433600906)"" AND ENCLOSES ""DEPTH GAUGE INNER BODY WITH BALL & SPRING - RM06009 (DI NO# 05060433600913)"". THIS CREATES THE FINAL INSTRUMENT IN626/1 - ""DEPTH GAUGE ASSEMBLY- AS01069 """
2020-07-24
LSSS - "DEPTH GAUGE OUTER BODY TUBE. THIS TUBE HOUSES THE ""DEPTH GAUGE INNER BODY WITH BALL & SPRING - RM06009 (DI NO# 05060433600913)"" AND HAS A CAP THAT FITS ONTO THE END OF IT CALLED ""DEPTH GAUGE OUTER BODY CAP - RM06010 (05060433600890)"". THIS CREATES THE FINAL INSTRUMENT IN626/1 - ""DEPTH GAUGE ASSEMBLY - AS01069"""
2020-07-24
LSSS - "DEPTH GAUGE INNER BODY WITH BALL & SPRING. THIS INNER TUBE HAS MARKINGS ON IT. IT SITS INSIDE THE ""DEPTH GAUGE OUTER BODY TUBE - RM06008 (DI NO# 05060433906)"". THIS CREATES THE FINAL INSTRUMENT IN626/1 - ""DEPTH GAUGE ASSEMBLY - AS01069"" "
2020-07-24
AC DEVICE - Lockdown AO Drill 2.5mm diameter (Sterile)
2017-02-23
LSSS - Lockdown Angled Intrducer for use on right shoulder - single use
2019-02-27
LSSS - Lockdown Angled Introducer for use on left shoulder - single use
2019-02-27
LSSS - Lockdown Loop Tensioner - Single Use
2019-02-27
AC DEVICE - Left Shoulder Single Use Instrument Pack
2019-02-27
AC DEVICE - Right Shoulder Single Use Instrument Kit
2019-02-27
AC DEVICE - 14mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS)
2015-10-30
AC DEVICE - 16mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS)
2015-10-30
AC DEVICE - 18mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS)
2015-10-30
AC DEVICE - 20mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS)
2015-10-30
AC DEVICE - 22mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS)
2015-10-30
AC DEVICE - 24mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS)
2015-10-30