ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY XE

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

Regulatory Submissions

510(k) Number: K133256

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	Device Class	Medical Specialty	Exempt	Created
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	NPJ	Class 2	Orthopedic	No	2014-04-25
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	Class 2	Orthopedic	No	2014-04-25
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	Class 2	Orthopedic	No	2014-04-25
Knee Arthroplasty Implantation System	OOG	Class 2	Orthopedic	No	2014-04-25

Proprietary Names

ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY XE IUNI G2 KNEE REPAIR ITOTAL TOTAL KNEE REPLACEMENT SYSTEM IUNI KNEE REPAIR SYSTEM ITOTAL IJIG COMPONENTS IDUO KRS IDUO IJIG COMPONENTS ITOTAL G2 CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL CR TOTAL KNEE REPLACEMENT IUNI G2 UNICONDYLAR KNEE REPLACEMENT ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL G2 IJIG COMPONENTS ITOTAL CR IJIG COMPONENTS IDUO G2 PARTIAL KNEE REPLACEMENT IDUO BICOMPARTMENTAL KNEE REPAIR ITOTAL G2 IJIG ANCILLARY INSTRUMENTS IUNI G2 ITOTAL G2 CRUCIATE RETAINING TOTAL KNEE REPLACEMENT IUNI G2 IJIG INSTRUMENTS ITOTAL G2 CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM CONFORMIS TOTAL KNEE REPAIR SYSTEM ITOTAL G2 CRUCIATE RETAINING IJIG COMPONENTS ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT ITOTAL CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL CR KNEE REPLACEMENT ITOTAL CR IJIG INSTRUMENTS ITOTAL IJIG INSTRUMENTS IDUO G2 BICOMPARTMENTAL RESURFACING SYSTEM IUNI ITOTAL G2 KNEE REPLACEMENT IDUO G2 KNEE REPAIR ITOTAL TOTAL KNEE REPLACEMENT ITOTAL CR CRUCIATE RETAINING IJIGS ITOTAL G2 KNEE REPLACEMENT SYSTEM IDUO G2 IJIG COMPONENTS IDUO IJIG ANCILLARY INSTRUMENTS ITOTAL G2 CRUCIATE RETAINING IJIG INSTRUMENTS ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM IUNI UNICONDYLAR KNEE REPAIR IDUO G2 BICOMPARTMENTAL KNEE REPAIR IDUO BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM IDUO IJIG INSTRUMENTS IDUO KNEE RESURFACING SYSTEM IDUO PARTIAL KNEE REPLACEMENT SYSTEM IUNI G2 IJIG ANCILLARY INSTRUMENTS ITOTAL KNEE REPLACEMENT SYSTEM IUNI G2 KNEE REPLACEMENT SYSTEM ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM ITOTAL CR INSERT iTotal: Tibial Component Extended Thickness Range IUNI IJIG ANCILLARY INSTRUMENTS IDUO G2 KNEE REPLACEMENT IDUO PARTIAL KNEE REPLACEMENT IDUO BICOMPARTMENTAL KNEE REPLACEMENT ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT IUNI IJIGS IUNI UNICONDYLAR KNEE RESURFACING SYSTEM ITOTAL G2 CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY ITOTAL CR KNEE REPLACEMENT SYSTEM ITOTAL CR KRS ITOTAL KRS ITOTAL IUNI G2 UNICONDYLAR KNEE RESURFACING SYSTEM ITOTAL CR IJIGS IUNI KNEE REPLACEMENT SYSTEM IDUO G2 KRS ITOTAL CR CRUCIATE RETAINING ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY XE IDUO G2 IJIG INSTRUMENTS IDUO G2 KNEE RESURFACING SYSTEM ITOTAL CR CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS IDUO KNEE RESURFACING IUNI G2 PARTIAL KNEE REPLACEMENT IUNI PARTIAL KNEE REPLACEMENT IUNI G2 IJIG COMPONENTS IUNI KNEE REPLACEMENT IUNI KRS IUNI G2 KNEE RESURFACING SYSTEM ITOTAL CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM IUNI UNICONDYLAR KNEE REPLACEMENT IUNI KNEE RESURFACING SYSTEM IDUO G2 BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM ITOTAL KNEE REPLACEMENT IDUO KNEE REPLACEMENT ITOTAL CR CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM WITH IPOLY ITOTAL CR CRUCIATE RETAINING KNEE REPLACEMENT IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING IUNI KNEE RESURFACING IDUO G2 IJIG ANCILLARY INSTRUMENTS ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT ITOTAL CR CRUCIATE RETAINING INSTRUMENT SET ITOTAL CR CRUCIATE RETAINING IJIG INSTRUMENTS IDUO IJIGS ITOTAL G2 CRUCIATE RETAINING KRS ITOTAL CRUCIATE RETAINING IJIGS ITOTAL IJIG ANCILLARY INSTRUMENTS IDUO ITOTAL CRUCIATE RETAINING TOTAL KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS IUNI G2 KRS IUNI G2 UNICONDYLAR KNEE REPAIR SYSTEM IDUO G2 BICOMPARTMENTAL KNEE REPLACEMENT IDUO BICOMPARTMENTAL RESURFACING SYSTEM IUNI IJIG INSTRUMENTS ITOTAL G2 CRUCIATE RETAINING IJIG ANCILLARY INSTRUMENTS IUNI G2 KNEE RESURFACING IDUO KNEE REPLACEMENT SYSTEM IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM IUNI G2 UNICONDYLAR KNEE REPAIR ITOTAL CR TOTAL KNEE REPLACEMENT SYSTEM IDUO G2 BICOMPARTMENTAL KNEE REPAIR SYSTEM ITOTAL G2 KRS IDUO G2 ITOTAL G2 CRUCIATE RETAINING KNEE REPLACEMENT SYSTEM IDUO KNEE REPAIR IUNI UNICONDYLAR KNEE REPAIR SYSTEM ITOTAL CR CRUCIATE RETAINING KRS ITOTAL CR ITOTAL G2 CRUCIATE RETAINING IJIGS IUNI KNEE REPAIR ITOTAL G2 TOTAL KNEE REPLACEMENT IDUO G2 BICOMPARTMENTAL RESURFACING IUNI G2 UNICONDYLAR KNEE RESURFACING IDUO BICOMPARTMENTAL RESURFACING IUNI UNICONDYLAR KNEE RESURFACING IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM IUNI G2 PARTIAL KNEE REPLACEMENT SYSTEM ITOTAL G2 IJIGS IDUO G2 KNEE RESURFACING IUNI G2 KNEE REPLACEMENT IDUO G2 IJIGS IDUO KNEE REPAIR SYSTEM ITOTAL CR CRUCIATE RETAINING IJIG COMPONENTS IUNI G2 IJIGS IDUO G2 KNEE REPAIR SYSTEM IUNI PARTIAL KNEE REPLACEMENT SYSTEM ITOTAL G2 CRUCIATE RETAINING IUNI IJIG COMPONENTS ITOTAL CRUCIATE RETAINING KRS ITOTAL CR CRUCIATE RETAINING STEINMAN PIN ITOTAL CR IJIG ANCILLARY INSTRUMENTS IDUO G2 KNEE REPLACEMENT SYSTEM ITOTAL CRUCIATE RETAINING TIBIAL TRAY ITOTAL G2 IJIG INSTRUMENTS ITOTAL IJIGS ITOTAL G2 IUNI G2 KNEE REPAIR SYSTEM IDUO G2 PARTIAL KNEE REPLACEMENT SYSTEM

Establishment Types

Manufacture Medical Device