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
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