Rotation Medical Inc

FDA Filings

This page includes the latest FDA filings for Rotation Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009351468
FEI Number3009351468
NameROTATION MEDICAL, INC
Owner & OperatorSmith & Nephew, Inc.
Contact Address7135 Goodlett Farms Parkway
Cordova TN 38016 US
Official Correspondent
  • Beth Zis
  • x-978-7491260-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address15350 25th Ave. No. Suite 100
Plymouth, MN 55447 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
ROTATION MEDICAL, INC.
Bioinductive Implant with Arthroscopic Delivery System - Large 45662019-08-28
ROTATION MEDICAL, INC.
Bioinductive Implant with Arthroscopic Delivery System - Medium 45652019-08-28
ROTATION MEDICAL, INC.
Bone Anchors with Arthroscopic Delivery System 2503-A2019-03-21
ROTATION MEDICAL, INC.
Bone Anchors with Arthroscopic Delivery System - Advanced 44032019-03-21
ROTATION MEDICAL, INC.
Rotation Medical Bone Staple 2019-03-21
ROTATION MEDICAL, INC.
Rotation Medical Bone Staple Drivers With Staples 2019-03-21
ROTATION MEDICAL, INC.
Rotation Medical Arthroscopic Implant Set With Staples 2516-12019-03-21
ROTATION MEDICAL, INC.
Rotation Medical Tendon Staples 2504-12019-01-08
ROTATION MEDICAL, INC.
Tendon Stabilizing Guide 44022018-03-29
ROTATION MEDICAL, INC.
Bioinductive Implant with Arthroscopic Delivery System - Medium 43972018-03-29
ROTATION MEDICAL, INC.
Bioinductive Implant with Arthroscopic Delivery System - Large 43992018-03-29
ROTATION MEDICAL, INC.
Bioinductive Implant with Arthroscopic Delivery System - Hybrid 44082018-03-29
ROTATION MEDICAL, INC.
Rotation Tendon Marker 2018-03-29
ROTATION MEDICAL, INC.
Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Hybrid 2018-03-29
ROTATION MEDICAL, INC.
Rotation Medical Mini-Open Implant Set With Staples 2018-03-29
ROTATION MEDICAL, INC.
Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Large 2018-03-29
ROTATION MEDICAL, INC.
Rotation Medical Reconstituted Collagen Scaffold - Mini-Open, Medium 2018-03-29
ROTATION MEDICAL, INC.
Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Large 2018-03-29
ROTATION MEDICAL, INC.
Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium 2018-03-29
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Bioinductive Implant; Collagen Tendon Sheet - Ddi2018-01-11
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Bioinductive Implant; Collagen Tendon Sheet - Ddi2018-01-11
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Rotation Medical Tendon Staples2018-01-11
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Rotation Medical Bone Staple Drivers with Staples Kit2018-01-11
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Collagen Tendon sheet-D2018-01-11
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Collagen Tendon sheet-D2018-01-11
ROTATION MEDICAL, INC.
COLLAGEN TENDON SHEET-DDI (CTS-DDI)2014-03-26
ROTATION MEDICAL, INC.
ROTATION MEDICAL BONE STAPLE (RMB STAPLE)2013-08-29
ROTATION MEDICAL, INC.
ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)2013-07-12
ROTATION MEDICAL, INC.
COLLAGEN TENDON SHEET-D2013-01-08
ROTATION MEDICAL, INC.
COLLAGEN TENDON SHEET2011-12-22
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
rail clamp, passing pin2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Wissinger Rod2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Universal Rachet Handle2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Tunnel Notcher2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Tunnel Expander2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Transverse Bullet2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Transverse Arm2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Toothless Shark Atraumatic Grasper2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Titan Removal Tool Capture Sleeve2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Titan Bone Punch2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Tibial Tunnel Plug2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Tapered Tap2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
TRIGEN2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
TANDEM2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Swordfish2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Suture Hook2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Suture Clamp Tension meter2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Small Joint Probe2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Slotted Tendon Harvester2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Slap Hammer2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Single Hole Knot Pusher2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Rotation Medical Mini-Open Instrument Kit2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Rotation Medical Arthroscopic Instrument Kit2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Removal Tool Driver2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Radial Clamp2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
REFLECTION2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Probe2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Point to Point, ACL Arm2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Point to Elbow, ACL Arm2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Piranha Junior2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Piranha Arthroscopic Rongeur2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Passing Pin Puller2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
PERI-LOC2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Tunnel Rasp2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Tibial Sheath Inserter2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Tibial Dilator2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Tibial Button Impactor2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Tendon Harvester2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Graft Sizing Block2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Femoral Drill Guide Trocar2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Disposables Kit2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Depth Gage2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
N8TIVE ACL Curette2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Multi-Sizing Block2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Metal Screw Driver Shaft2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Meniscal Rasp2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Meniscal Lift2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
MegaMouth Grasper2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Marlin2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Manta2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Long Probe2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Lobster Claw Suture Retriever2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Jaws Tigar Shark Grasper2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Jaws Retro Toothed Grasper2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Jaws Retro Junior Grasper2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Jaws Great White Grasper2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
JOURNEY2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Inserter Tip2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Hammerhead Rotary Scissor2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Hammerhead Rotary Punch2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Guidewire Aimer2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Graft, Tissue Clamp2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Graft, Suture Clamp2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Graft, Base Lock2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Graft Board Hook2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Graft Bar Holder2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Graft Assist, Board2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Femoral Locator2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Femoral Aimer2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Elevator Rasp2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
EMPERION2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Depth Probe2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Cuff Elevator2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Crochet Hook2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Closed Tendon Harvester2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Clearcut Suture Cutter2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Chondral Pick2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Cannulated Switching Stick2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Cannula Driver2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Bone Tap2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Blunt Nose Junior2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Bilok ST Graft Expander2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Beluga Retro2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Awl, tap, driver, dilator2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Ankle Distractor2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Ankle Distractor Strap2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
Adaptor2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
ACL Tunnel Rasp2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
ACL Open Curette2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
ACL Disposables Kit2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
ACL Disposables Guidewire Kit2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
ACL Closed Curette2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
ACL Bullet2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
A-Tech Femoral Locator Handle2006-10-05
ROTATION MEDICAL, INC [Smith & Nephew, Inc.]
A-Tech Controlled Flexion Guidewire2006-10-05

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