FDA Registration Active 🇺🇸 United States

ITOTAL TIBIAL DRILL GUIDE SLEEVE

Reg #: 3004153240 · FEI: 3004153240 · Expires 2025
Products
1
Proprietary Names
394
Establishment Types
1
Classifications
1

Registration Details

Registration Name
ConforMIS, Inc.
Registration Number
3004153240
FEI Number
3004153240
Status
Active
Expiry Year
2025
Initial Importer
No
Address
600 Research Dr
City
Wilmington
State
MA
ZIP
01887
Country
US

Owner / Operator

Firm Name
restor3d, Inc.
Operator Number
9058483
Address
4001 NC-54, Suite 3160
City
Durham
State
NC
Postal Code
27709
Country
US
Correspondent
Brianna Prindle

Products

Device Name Product Code
Orthopedic Manual Surgical Instrument LXH

Proprietary Names

ITOTAL TIBIAL DRILL GUIDE SLEEVE ITOTAL G2 CRUCIATE RETAINING TIBIAL DRILL BIT ITOTAL CR TOWNLEY CALIPER IDUO G2 PATELLA DRILL BIT WITH STOP ITOTAL G2 PATELLA SET ITOTAL CRUCIATE RETAINING KEEL PUNCH ITOTAL G2 TIBIAL TRAY IMPACTOR TIP ITOTAL TRAY IMPACTOR TIP ITOTAL CRUCIATE RETAINING KEEL PUNCH TIPS ITOTAL CRUCIATE RETAINING POLY INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING GUIDANCE PLUG ITOTAL G2 REUSABLE INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL CR CRUCIATE RETAINING PATELLA CLAMP ITOTAL CR CRUCIATE RETAINING KEEL PUNCH IDUO G2 PATELLA REUSUABLE INSTRUMENT SET ITOTAL CR OSTEOTOMY GUIDE ITOTAL DRILL SLEEVE IDUO G2 REUSABLE INSTRUMENT TRAY ITOTAL G2 CRUCIATE RETAINING UNIVERSAL IMPACTOR HEAD ITOTAL CR TIBIAL DRILL GUIDE SLEEVE IDUO PATELLA SIZER ITOTAL CR PATELLA TRAY ITOTAL G2 CRUCIATE RETAINING PATELLA TRIAL ITOTAL CR CRUCIATE RETAINING TIBIAL STEM DRILL BIT ITOTAL CR DRILL SLEEVE ITOTAL G2 CRUCIATE RETAINING POLY IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING DRILL BIT ITOTAL PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL CR GUIDANCE PLUG IDUO G2 CALIPER ITOTAL CR CRUCIATE RETAINING STEM DRILL BIT ITOTAL REUSABLE INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING PATELLA SET ITOTAL CR TIBIAL DRILL BIT ITOTAL CR POLY INSERT IMPACTOR TIP ITOTAL CRUCIATE RETAINING STERILIZATION TRAY ITOTAL CRUCIATE RETAINING INSTRUMENT TRAY ITOTAL CR PATELLA TRIAL ITOTAL CR CRUCIATE RETAINING PIN PULLER ITOTAL G2 CRUCIATE RETAINING TRAY IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING INSERT IMPACTOR TIP ITOTAL TACK PIN IDUO G2 PATELLA TRIAL ITOTAL CR INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING TIBIAL DRILL GUIDE SLEEVE ITOTAL CR CRUCIATE RETAINING IMPACTOR HANDLE IDUO REUSABLE INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING PATELLA INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING TIBIAL DRILL GUIDE SLEEVE IDUO G2 PATELLA SIZER ITOTAL CR CRUCIATE RETAINING UNIVERSAL IMPACTOR HANDLE ITOTAL CR CRUCIATE RETAINING INSTRUMENT SET ITOTAL PATELLA SET ITOTAL CR UNIVERSAL IMPACTOR HANDLE ITOTAL G2 CORING TOOL ITOTAL CRUCIATE RETAINING FEMORAL DRILL BIT ITOTAL UNIVERSAL IMPACTOR HANDLE ITOTAL CRUCIATE RETAINING TOWNLEY CALIPER ITOTAL G2 TRAY IMPACTOR TIP ITOTAL G2 CRUCIATE RETAINING PIN PULLER ITOTAL CR PIN PULLER IDUO PATELLA CLAMP ITOTAL OSTEOTOMY GUIDE ITOTAL G2 CRUCIATE RETAINING TOWNLEY CALIPER ITOTAL DRILL GUIDE SLEEVE ITOTAL GUIDANCE PLUG ITOTAL G2 CRUCIATE RETAINING PATELLA SIZER ITOTAL CR STERILIZATION TRAY ITOTAL G2 CRUCIATE RETAINING CALIPER ITOTAL G2 CRUCIATE RETAINING DRILL SLEEVE ITOTAL G2 CRUCIATE RETAINING PATELLA INSTRUMENT SET IDUO PATELLA DRILL BIT ITOTAL G2 PATELLAR OSTEOTOMY GUIDE ITOTAL IMPACTOR HANDLE ITOTAL G2 CRUCIATE RETAINING STEM DRILL BIT ITOTAL CR CRUCIATE RETAINING PATELLA INSTRUMENT TRAY ITOTAL G2 CRUCIATE RETAINING TIBIAL STEM DRILL BIT ITOTAL CRUCIATE RETAINING GUIDANCE PLUG ITOTAL CRUCIATE RETAINING PATELLA DRILL BIT WITH STOP ITOTAL CR STEINMAN PIN ITOTAL CR STEM DRILL BIT ITOTAL CRUCIATE RETAINING DRILL GUIDE SLEEVE ITOTAL CRUCIATE RETAINING DRILL BIT WITH STOP IDUO G2 INSTRUMENT TRAY ITOTAL FEMORAL DRILL BIT ITOTAL G2 STEM DRILL BIT ITOTAL PATELLA CLAMP ITOTAL CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT SET ITOTAL G2 KEEL PUNCH ITOTAL CALIPER ITOTAL CR CRUCIATE RETAINING DRILL BIT WITH STOP IDUO G2 PATELLA CLAMP ITOTAL REUSABLE INSTRUMENT TRAY ITOTAL CR CRUCIATE RETAINING POLY INSERT IMPACTOR TIP ITOTAL PATELLA REUSUABLE INSTRUMENT SET ITOTAL G2 IMPACTOR HANDLE ITOTAL TIBIAL STEM DRILL BIT ITOTAL G2 CRUCIATE RETAINING INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING DRILL BIT WITH STOP ITOTAL CR CRUCIATE RETAINING STEINMAN PIN ITOTAL CRUCIATE RETAINING STEM DRILL BIT ITOTAL G2 PATELLA TRIAL ITOTAL CR INSTRUMENT TRAY ITOTAL G2 PATELLA SIZER ITOTAL STEINMAN PIN IDUO STERILIZATION TRAY ITOTAL CR IMPACTOR HANDLE ITOTAL G2 REUSABLE INSTRUMENT SET IDUO REUSABLE INSTRUMENT TRAY ITOTAL G2 OSTEOTOMY GUIDE ITOTAL CR PATELLA SIZER ITOTAL CRUCIATE RETAINING INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING PATELLA TRAY ITOTAL G2 CRUCIATE RETAINING IMPACTOR HANDLE ITOTAL INSTRUMENT TRAY ITOTAL G2 PATELLA INSTRUMENT TRAY ITOTAL CR REUSABLE INSTRUMENT SET ITOTAL G2 TIBIAL DRILL BIT ITOTAL ALIGNMENT ROD ITOTAL CRUCIATE RETAINING TIBIAL STEM DRILL BIT ITOTAL CR CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT SET IDUO PATELLA REUSUABLE INSTRUMENT TRAY IDUO INSTRUMENT SET IDUO OSTEOTOMY GUIDE IDUO DRILL BIT WITH STOP ITOTAL CRUCIATE RETAINING DRILL SLEEVE ITOTAL G2 POLY INSERT IMPACTOR TIP ITOTAL POLY INSERT IMPACTOR TIP ITOTAL CRUCIATE RETAINING UNIVERSAL IMPACTOR HEAD ITOTAL CRUCIATE RETAINING REUSABLE INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING PATELLA INSTRUMENT TRAY ITOTAL G2 DRILL BIT WITH STOP IDUO PATELLA DRILL BIT WITH STOP ITOTAL CRUCIATE RETAINING TRAY IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING CORING TOOL ITOTAL TOWNLEY CALIPER ITOTAL CRUCIATE RETAINING UNIVERSAL IMPACTOR HANDLE ITOTAL CR PATELLA CLAMP ITOTAL CRUCIATE RETAINING PATELLAR OSTEOTOMY GUIDE ITOTAL G2 CRUCIATE RETAINING POLY INSERT IMPACTOR TIP IDUO PATELLA TRIAL ITOTAL G2 CRUCIATE RETAINING TIBIAL INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING CALIPER ITOTAL KEEL PUNCH TIPS ITOTAL CR CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING TIBIAL DRILL BIT ITOTAL G2 CRUCIATE RETAINING TIBIAL TRAY IMPACTOR TIP ITOTAL G2 CRUCIATE RETAINING ALIGNMENT ROD ITOTAL CR CRUCIATE RETAINING TOWNLEY CALIPER ITOTAL G2 PATELLA TRAY ITOTAL PATELLA INSTRUMENT TRAY ITOTAL POLY IMPACTOR TIP ITOTAL INSERT IMPACTOR TIP ITOTAL CRUCIATE RETAINING STEINMAN PIN ITOTAL G2 CRUCIATE RETAINING REUSABLE INSTRUMENT SET ITOTAL G2 UNIVERSAL IMPACTOR HEAD ITOTAL CORING TOOL IDUO G2 STERILIZATION TRAY ITOTAL CR TIBIAL STEM DRILL BIT ITOTAL G2 TIBIAL STEM DRILL BIT IDUO G2 REUSABLE INSTRUMENT SET IDUO G2 PATELLA DRILL BIT ITOTAL CR CRUCIATE RETAINING UNIVERSAL IMPACTOR HEAD ITOTAL CRUCIATE RETAINING PATELLA TRIAL ITOTAL CRUCIATE RETAINING CORING TOOL IDUO G2 PATELLA TRAY ITOTAL CRUCIATE RETAINING TIBIAL TRAY IMPACTOR TIP ITOTAL G2 CALIPER IDUO PATELLA SET ITOTAL CR REUSABLE INSTRUMENT TRAY ITOTAL G2 KEEL PUNCH TIPS ITOTAL G2 CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING UNIVERSAL IMPACTOR HANDLE ITOTAL G2 PIN PULLER ITOTAL DRILL BIT ITOTAL CRUCIATE RETAINING DRILL BIT IDUO G2 PATELLA INSTRUMENT SET IDUO G2 PATELLAR OSTEOTOMY GUIDE ITOTAL CR CORING TOOL ITOTAL PATELLA DRILL BIT WITH STOP ITOTAL DRILL BIT WITH STOP ITOTAL G2 PATELLA REUSUABLE INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING TIBIAL DRILL BIT ITOTAL G2 CRUCIATE RETAINING PATELLA CLAMP IDUO G2 DRILL BIT ITOTAL G2 CRUCIATE RETAINING KEEL PUNCH ITOTAL CRUCIATE RETAINING PATELLA INSTRUMENT TRAY ITOTAL G2 TOWNLEY CALIPER ITOTAL G2 PATELLA DRILL BIT WITH STOP ITOTAL G2 FEMORAL DRILL BIT ITOTAL PATELLA TRIAL ITOTAL CR TACK PIN IDUO G2 INSTRUMENT SET ITOTAL G2 TIBIAL DRILL GUIDE SLEEVE ITOTAL G2 INSERT IMPACTOR TIP IDUO G2 PATELLA SET ITOTAL CR CRUCIATE RETAINING TACK PIN ITOTAL CR CRUCIATE RETAINING INSTRUMENT TRAY IDUO G2 TOWNLEY CALIPER ITOTAL CR DRILL BIT WITH STOP ITOTAL G2 CRUCIATE RETAINING PATELLA DRILL BIT ITOTAL G2 TIBIAL INSERT IMPACTOR TIP ITOTAL G2 CRUCIATE RETAINING TACK PIN ITOTAL G2 STERILIZATION TRAY ITOTAL CRUCIATE RETAINING POLY IMPACTOR TIP IDUO PATELLA INSTRUMENT TRAY ITOTAL G2 CRUCIATE RETAINING DRILL BIT ITOTAL PATELLAR OSTEOTOMY GUIDE ITOTAL PATELLA TRAY ITOTAL CR CRUCIATE RETAINING PATELLA TRIAL ITOTAL CRUCIATE RETAINING TIBIAL DRILL GUIDE SLEEVE ITOTAL CR TIBIAL INSERT IMPACTOR TIP IDUO G2 PATELLA INSTRUMENT TRAY IDUO PATELLA TRAY IDUO INSTRUMENT TRAY ITOTAL CR POLY IMPACTOR TIP ITOTAL G2 DRILL BIT ITOTAL CR PATELLA INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING TIBIAL TRAY ITOTAL CR INSERT ITOTAL G2 DRILL GUIDE SLEEVE ITOTAL CR INSTRUMENT SET ITOTAL CR FEMORAL DRILL BIT ITOTAL G2 CRUCIATE RETAINING STERILIZATION TRAY ITOTAL G2 CRUCIATE RETAINING INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING REUSABLE INSTRUMENT TRAY IDUO DRILL BIT ITOTAL CR CRUCIATE RETAINING TRAY IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING PATELLA DRILL BIT WITH STOP ITOTAL G2 DRILL SLEEVE ITOTAL TIBIAL INSERT IMPACTOR TIP ITOTAL STERILIZATION TRAY IDUO G2 OSTEOTOMY GUIDE IDUO G2 DRILL BIT WITH STOP ITOTAL CR CRUCIATE RETAINING PATELLA SIZER IDUO G2 PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL G2 POLY IMPACTOR TIP ITOTAL G2 CRUCIATE RETAINING PATELLA REUSUABLE INSTRUMENT TRAY IDUO PATELLA INSTRUMENT SET ITOTAL CRUCIATE RETAINING PATELLA TRAY IDUO CALIPER ITOTAL CRUCIATE RETAINING INSTRUMENT SET ITOTAL G2 PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL TIBIAL TRAY IMPACTOR TIP ITOTAL G2 CRUCIATE RETAINING PATELLA TRAY ITOTAL G2 UNIVERSAL IMPACTOR HANDLE ITOTAL CRUCIATE RETAINING PATELLA INSTRUMENT SET ITOTAL TIBIAL DRILL BIT ITOTAL CR UNIVERSAL IMPACTOR HEAD ITOTAL CR PATELLA REUSUABLE INSTRUMENT TRAY ITOTAL CR PATELLA SET ITOTAL CR CALIPER ITOTAL INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING REUSABLE INSTRUMENT TRAY IDUO TOWNLEY CALIPER ITOTAL CR PATELLAR OSTEOTOMY GUIDE ITOTAL CR CRUCIATE RETAINING TIBIAL TRAY IMPACTOR TIP ITOTAL G2 TACK PIN ITOTAL CRUCIATE RETAINING TACK PIN ITOTAL CRUCIATE RETAINING PATELLA DRILL BIT ITOTAL UNIVERSAL IMPACTOR HEAD ITOTAL PATELLA INSTRUMENT SET ITOTAL CR TRAY IMPACTOR TIP ITOTAL PIN PULLER ITOTAL G2 PATELLA CLAMP ITOTAL G2 CRUCIATE RETAINING STEINMAN PIN ITOTAL G2 CRUCIATE RETAINING PATELLA DRILL BIT WITH STOP ITOTAL CR KEEL PUNCH TIPS ITOTAL G2 INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING STERILIZATION TRAY ITOTAL CR DRILL GUIDE SLEEVE ITOTAL G2 CRUCIATE RETAINING PATELLAR OSTEOTOMY GUIDE ITOTAL CR CRUCIATE RETAINING FEMORAL DRILL BIT ITOTAL CRUCIATE RETAINING PATELLA CLAMP ITOTAL PATELLA DRILL BIT ITOTAL CR TIBIAL TRAY IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING OSTEOTOMY GUIDE ITOTAL CR CRUCIATE RETAINING PATELLAR OSTEOTOMY GUIDE ITOTAL G2 CRUCIATE RETAINING INSTRUMENT TRAY ITOTAL CR PATELLA INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING PATELLA SET ITOTAL G2 STEINMAN PIN IDUO PATELLA REUSUABLE INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING CORING TOOL ITOTAL CRUCIATE RETAINING PATELLA SIZER ITOTAL CRUCIATE RETAINING ALIGNMENT ROD ITOTAL STEM DRILL BIT ITOTAL CRUCIATE RETAINING CALIPER ITOTAL G2 PATELLA INSTRUMENT SET ITOTAL G2 CRUCIATE RETAINING FEMORAL DRILL BIT ITOTAL CR KEEL PUNCH ITOTAL CRUCIATE RETAINING PIN PULLER ITOTAL G2 INSTRUMENT TRAY ITOTAL CRUCIATE RETAINING TIBIAL INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING ALIGNMENT ROD IDUO PATELLAR OSTEOTOMY GUIDE ITOTAL G2 CRUCIATE RETAINING KEEL PUNCH TIPS ITOTAL CR CRUCIATE RETAINING TIBIAL INSERT IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING PATELLA DRILL BIT ITOTAL CRUCIATE RETAINING IMPACTOR HANDLE ITOTAL CRUCIATE RETAINING REUSABLE INSTRUMENT TRAY ITOTAL G2 CRUCIATE RETAINING OSTEOTOMY GUIDE ITOTAL G2 ALIGNMENT ROD ITOTAL G2 CRUCIATE RETAINING DRILL GUIDE SLEEVE ITOTAL CRUCIATE RETAINING PATELLA SET ITOTAL CR ALIGNMENT ROD ITOTAL CR PATELLA DRILL BIT WITH STOP ITOTAL CR PATELLA DRILL BIT ITOTAL CRUCIATE RETAINING OSTEOTOMY GUIDE ITOTAL PATELLA SIZER ITOTAL G2 CRUCIATE RETAINING GUIDANCE PLUG ITOTAL CR CRUCIATE RETAINING REUSABLE INSTRUMENT SET ITOTAL KEEL PUNCH ITOTAL CR PATELLA REUSUABLE INSTRUMENT SET ITOTAL CR DRILL BIT ITOTAL G2 PATELLA DRILL BIT ITOTAL CR CRUCIATE RETAINING KEEL PUNCH TIPS ITOTAL CR CRUCIATE RETAINING POLY IMPACTOR TIP ITOTAL CR CRUCIATE RETAINING DRILL SLEEVE ITOTAL G2 GUIDANCE PLUG ITOTAL CR CRUCIATE RETAINING DRILL GUIDE SLEEVE Offset Cup Impactor Enztec Cordera Acetabular Reusable Instrument Tray insert and base Blunt Steinman Pins Cordera Femoral Reusable Instrument Tray insert and base T-handle Quick Connect Femoral Stem Extractor Handle Extension iTotal Poly Impactor iTotal Keel Punch Tips, PS or CR, Serrated or Non-serrated iTotal/ Identity/ Imprint Femoral Plug Femoral Stem Extractor Handle Trifecta Universal Reusable Instrument Lid 1080-125 Femoral Stem Extractor Loop Adaptor OrthoGroup Cup Impactor Trifecta Identity Reusable Instrument Tray with Insert 1080-127 Hip Broach Handle Offset left Femoral Stem Extractor Straight Adaptor Threaded Offset Reamer Driver Enztec Identity/ Imprint Patellar Osteotomy Guide Actera Trial Necks single Use DRILL, DIA 5.5MM X 79MM, W/STOP Acetabular Cup Impactor Modular Box Osteotome 8MM X 20MM Pin Puller Acetabular reamer handle and sleeve Threaded Headed Pin Flex drills: 3.5mm x 35mm; 3.5mm x 50mm; 5.5mm x 25mm Depth gauge Identity Imprint Porous half keel punches: small, medium, large Ratcheting Quick-Connect Handle iTotal STEM DRILL 12MM W/ HUDSON ADAPTOR Femoral Stem Impactor, offset Femoral Head Impactor Hip Broach Handle Neutral Screw Holding forceps iTotal Impactor Head iTotal Patella Implant sizers Screw driver- rigid and flexible ITOTAL FEMORAL DRILL BIT 8MM W/ HUDSON ADAPTOR iTotal STEM DRILL 10MM W/ HUDSON ADAPTOR Drill Guide, double ended Calcar Planer Adaptor iTotal CORING TOOL W/ HUDSON ADAPTOR Femoral Rasp ANGEL WING RESECTION GUIDE Femoral canal finder Femoral Stem Impactor Bone Rasp Hip Broach Handle Offset right Identity Imprint Porous Patella Clamp screw driver handle Tapered Femoral Reamer iTotal iPoly Impactor Tip iTotal Patella trials PATELLA, DRILL BIT, 5.5MM W/ HUDSON ADAPTOR 3.5MM Hex U-Joint Driver Broach Handles Gen 2 Neutral, offset right, offset left iDuo Patella Trials PATELLA CLAMP ASSEMBLY iDuo Patella Implant Sizers Universal Trail Heads: 28MM, 32MM, 38MM, 40MM Identity Imprint Porous Steering Femoral Inserter ITOTAL STEM DRILL 14MM W/ HUDSON ADAPTOR iTotal PS Tibial Tray Impactor tip Femoral Head Remover Identity Imprint Porous Patella Drill bits ITOTAL STEINMAN PIN 3.18MM Drill Guide Calcar Planer iTotal Alignment Rod Taper 150mm iTotal Identity Impactor Handle Calcar Planer Adaptor Short Threaded Cup Impactor Long

Establishment Types

Manufacture Medical Device