FDA Registration Active 🇺🇸 United States

INTEGRITY ORTHOPAEDICS, INC.

Reg #: 3026368553 · FEI: 3026368553 · Expires 2026
Products
2
Proprietary Names
246
Establishment Types
1
Classifications
2

Registration Details

Registration Name
INTEGRITY ORTHOPAEDICS, INC.
Registration Number
3026368553
FEI Number
3026368553
Status
Active
Expiry Year
2026
Initial Importer
No
Address
5565 Pioneer Creek Drive
City
Maple Plain
State
MN
ZIP
55359
Country
US

Regulatory Submissions

510(k) Number
K222589

Owner / Operator

Firm Name
Smith & Nephew, Inc.
Operator Number
1020279
Address
2875 Railroad Street
City
Pittsburgh
State
PA
Postal Code
15222
Country
US
Correspondent
Lisa Ewing

Products

Device Name Product Code
Orthopedic Manual Surgical Instrument LXH
Fastener, Fixation, Nondegradable, Soft Tissue MBI

Proprietary Names

Closed Tendon Harvester ACL Closed Curette Elevator Rasp Bone Tap Point to Point, ACL Arm Swordfish Meniscal Rasp N8TIVE ACL Disposables Kit Multi-Sizing Block ACL Bullet Hammerhead Rotary Punch Meniscal Lift Piranha Junior ACL Disposables Guidewire Kit Passing Pin Puller Titan Removal Tool Capture Sleeve Graft, Base Lock Blunt Nose Junior Cannulated Switching Stick Graft, Suture Clamp N8TIVE ACL Tunnel Rasp Clearcut Suture Cutter Hammerhead Rotary Scissor ACL Disposables Kit Suture Clamp Tension meter N8TIVE ACL Tibial Dilator Suture Hook Bilok ST Graft Expander N8TIVE ACL Curette N8TIVE ACL Femoral Drill Guide Trocar Tunnel Expander Manta Piranha Arthroscopic Rongeur N8TIVE ACL Tibial Sheath Inserter Universal Rachet Handle ACL Open Curette N8TIVE ACL Tibial Button Impactor Beluga Retro Titan Bone Punch Crochet Hook N8TIVE ACL Depth Gage Jaws Retro Toothed Grasper N8TIVE ACL Graft Sizing Block Femoral Aimer MegaMouth Grasper Jaws Retro Junior Grasper Guidewire Aimer Chondral Pick Wissinger Rod Jaws Great White Grasper A-Tech Femoral Locator Handle N8TIVE ACL Tendon Harvester Radial Clamp Tunnel Notcher Tibial Tunnel Plug Toothless Shark Atraumatic Grasper Graft, Tissue Clamp Transverse Arm Ankle Distractor Small Joint Probe Point to Elbow, ACL Arm Transverse Bullet Marlin Long Probe ACL Tunnel Rasp Single Hole Knot Pusher Graft Board Hook A-Tech Controlled Flexion Guidewire Metal Screw Driver Shaft Probe Femoral Locator Lobster Claw Suture Retriever Cuff Elevator Removal Tool Driver; MTO DRIVER 3.5MM 1.5MM CANN W/HUD ADAP; MTO DRIVER BIORCI W/HUDSON ADAPTOR Graft Bar Holder Jaws Tigar Shark Grasper Cannula Driver Ankle Distractor Strap Graft Assist, Board TRIGEN Slap Hammer Tapered Tap Depth Probe Slotted Tendon Harvester REFLECTION EMPERION Adaptor JOURNEY Inserter Tip Rotation Medical Mini-Open Instrument Kit PERI-LOC Rotation Medical Arthroscopic Instrument Kit TANDEM Integra Glenoid Holder GENESIS Integra Surgical Instrument - Driver LARGE QWIX QWIX Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile PANTA 1.5mm Guidewire, 12", 72202189 Cannuflex 9" Blunt Guidewire, 72202807 Integra Surgical Instrument Set Awl straight 3.8mm, 72202986 Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361 Accu-pass suture shuttle, crescent, 7210427 Wire and pin pac (C) Integra Pin Puller Accu-pass suture shuttle, Big Curve Accu-pass suture shuttle left 45 degree, 7210423 Integra Surgical Instrument - Planer Accu-pass suture shuttle 45 degree up, 7210425 LABELS FOR RING MODULE TIBIAXYS Guidewire 1.5mm x 229mm Suretac 6mm Guidewire, 72202809 Accu-pass suture shuttle, straight, 7210426 Twinfix AB 5mm threaded dilator, 72200819 Endobutton Pin Passing 2.4mm Trocar Round Oval Sizing Guide Wire and pin pac (B) Beath pin 2.4mm, 72202815 Biosure 1.2mm x 18", 72201201 Guide wire 2mm, 15", 7207222 Wire and pin pac, 7207738 Guidewire 2.4mm Drill Tip, guide wire, 12", 7207221 Guidewire, Nitinol 1.2mm x 45cm Accu-pass suture shuttle 70 degree, Upbend, 72200419 Passing pin Spade tip 3mm, 72202814 guide wire 2mm Accu-pass suture shuttle right 45 degree Awl tapered 3.8mm Twinfix AB 6.5mm threaded dilator, 72200820 Pliers, Compaction, 9MM PCL Guidewire, 7207284 Arthroscopic needle, 72202825 Awl, tap, driver, dilator MAVERICK MINI Extremities Guide, Universal TWINFIX 3.8 MM STRAIGHT AWL, REUSABLE RCI 7.5 MM TIBIAL STEPPED ROUTER SWISS RAIL CLAMP (LATERAL DSTRCTR SYS) RCI 7.5 MM FEMORAL STEPPED ROUTER 8MM TENDON FORK KNEE HOLDER CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE SMALL INSERTER DSP MTO GUIDEWIRE THREADED 1.5MM X 45CM SUTURE NEEDLE SHUTTLE STERILE 3.5 MM DILATOR GUIDEWIRE CANNFLEX 9 BLUNT TIP EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH US LATERAL RAIL CLAMP 2 RCI 7 MM FEMORAL STEPPED ROUTER OPEN CURETTE 6MM REVERSE CUT XL 6.5MM DILATOR US SUPINE RAIL CLAMPS 2, 0.375 INCH X 1.125 INCH 1 CM X 2.9 CM WHIPKNOT SOFT TISSUE CINCH 5 SUTURE 2.7 MM DILATOR DENYER RAIL CLAMP (LATERL DSTRCTR SYS) Rotation Tendon Marker AWL STRAIGHT 3.8MM DISPOSABLE TruKor Gauge LOCKING WRENCH 8MM BICEPTOR TAP MANUAL INSTRUMENT TRAY OPEN CURETTE 4.5MM XL Tendon Stabilizing Guide 7MM DILATOR MTO AWL-DILATOR TF ULTRA 4.5 CORTICAL BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS RCI 8.5 MM FEMORAL STEPPED ROUTER RCI 6.5 MM FEMORAL STEPPED ROUTER BI-GRIP PIN PULLER GUIDE WIRE BEATH PIN 2.4 MM STERILE 7MM TENDON FORK SWISS RAIL CLAMP (SUPINE DSTRCTR SYS) PASSING PIN, 3 MM, SPADE TIP RCI 6.5 MM TIBIAL STEPPED ROUTER WELL LEG HOLDER WITH LEATHER BOOT TWINFIX AB 6.5 THREADED DILATOR TROCAR-TIP PASSING PIN, 2.4 MM X 17 INCH, STERILE STITCHER 9MM TENDON FORK ARTHROSCOPIC NEEDLE STERILE REPLACEMENT LEATHER BOOT 1 TWINFIX AB 5 THREADED DILATOR SCREW GUIDE WIRE, 2 MM X 12 INCH 30CM, BLUNT TIP, STERILE 6 PER PACKAGE STYLET FOR STITCHER 6.5 MM DILATOR RCI 8.5 MM TIBIAL STEPPED ROUTER LOOP TIP GUIDEWIRE MTO TWINFIX ULTRA 5.5 FOR 5.5 CANNULA UNIVERSAL HIP DISTRACTOR WITH LEATHER BOOT ACCU-PASS STR SHTL BIG C STERILE BOX 1 7.5MM DILATOR MTO,SCRW DRVR,LOCKING, 2.5MM HEX, CANN GUIDE WIRE 1.2MM X 9 BOX OF 5 STERILE HAMMER SLAP DILATOR SYSTEM 4.5 MM DILATOR 7MM BICEPTOR TAP GUIDE WIRE PCL 2.4MM X10 KNOT PUSHER XL 12MM DILATOR MTO GUIDE WIRE AC JOINT 2.4 MM PLIERS, COMPACTION, 9mm ACCUPASS STR SHUTL MONOFIL -SEE72201361 1.5 MM TENDON DRILL PIN LARGE TENDON STRIPPER, CLOSED, 7.4 MM I.D. X 13.5 INCH WORKING LENGTH RCI 8 MM TIBIAL STEPPED ROUTER PERINEAL POST ARTHROPIERCE XL STRAIGHT RCI 7 MM TIBIAL STEPPED ROUTER EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS) LARGE INSERTER DSP RCI 8 MM FEMORAL STEPPED ROUTER GUIDE WR 1.2MM X 12 BOX OF 5 STERILE 8.5 MM DILATOR 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE DIRECTOR PCL ELEVATOR WITH WIRE CATCHER GD WIRE NITINOL 1.2 X 45CM 8MM DILATOR Drill for Q-FIX with Needles 9MM DILATOR ACCU-PASS SUTURE SHUTTLE 70 DEGREE 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS 6MM DILATOR TENDON STRIPPER CLOSED TENDON STRIPPER, SLOTTED, 5 MM I.D. X 12 INCH WORKING LENGTH MTO AWL-DIL TF ULTRA 5.5/6.5 CORTICAL 9.5MM DILATOR SUPINE TABLE ATTACHMENT PAD SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM, BLUNT TIP, STERILE BOARD, PATIENT TRANSFER ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE DENYER SUPINE RAIL CLAMPS 2 8.5MM DILATOR 10MM DILATOR GUIDE WIRE 1.2MM X18 BX OF 5 STER. 11MM DILATOR rail clamp, passing pin Tendon Seam Instrument Kit - 8 Anchor Tendon Seam Magazine - 4 Anchor Tendon Seam Magazine - 8 Anchor Tendon Seam Instrument Kit - 4 Anchor

Establishment Types

Manufacture Medical Device