ARTHROSURFACE, INC.

Registration Details

Registration Name: ARTHROSURFACE, INC.
Registration Number: 3004154314
FEI Number: 3004154314
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 319 Manley St
City: W Bridgewater
State: MA
ZIP: 02379
Country: US

Regulatory Submissions

510(k) Number: K133835

Owner / Operator

Firm Name: Arthrosurface, Inc.
Operator Number: 9058162
Address: 319 Manley St, --
City: W Bridgewater
State: MA
Postal Code: 02379
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Washer, Bolt Nut	HTN	Class 2	Orthopedic	No	2014-10-08
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	Class 1	General, Plastic Surgery	No	2014-01-09
Shoulder Prosthesis, Reverse Configuration	PHX	Class 2	Orthopedic	No	2021-10-26
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	Class 2	Orthopedic	No	2018-07-10
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	Class 2	Orthopedic	No	2018-07-10
Prosthesis, Ankle, Uncemented, Non-Constrained	NTG	Class 3	Unknown	No	2017-09-13
Screw, Fixation, Bone	HWC	Class 2	Orthopedic	No	2014-10-08
Orthopedic Manual Surgical Instrument	LXH	Class 1	Orthopedic	No	2004-06-02
Prosthesis, Toe, Hemi-, Phalangeal	KWD	Class 2	Orthopedic	No	2020-02-05
Prosthesis, Knee, Hemi-, Femoral	HSA	Class 3	Orthopedic	No	2017-09-13
Prosthesis, Hip, Femoral, Resurfacing	KXA	Class 2	Orthopedic	No	2007-11-20
Plate, Fixation, Bone	HRS	Class 2	Orthopedic	No	2012-08-22
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	Class 2	Orthopedic	No	2018-07-26
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained	LZJ	Class U	Unknown	No	2014-10-08
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	Class 2	Orthopedic	No	2008-03-25
Prosthesis, Wrist, Carpal Scaphoid	KWO	Class 2	Orthopedic	No	2016-01-20
Prosthesis, Wrist, Carpal Lunate	KWN	Class 2	Orthopedic	No	2016-01-20
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	JWJ	Class 2	Orthopedic	No	2021-01-04

Proprietary Names

KISSLocTM Suture System Bunion Reamer 40mm Starter Reamer, Humeral Head OVOMotion Reverse Shoulder Arthroplasty System RevoMotion Reverse Total Shoulder Arthroplasty System OVOMotion Shoulder Arthroplasty System HemiCAP Humeral Head Resurfacing HemiCAP® Talar Contoured Articular Prosthesis HammerToe Correction System OsteoMATE Instruments AlignMATE Instruments Glenojet Instruments SpeedSpiral Instruments SpiralUp Instrument Kits HemiCAP Instrument Kits NanoFx Microfracture Instrument BOSS Toe Fixation System HemiCAP Unicondylar Femoral Resurfacing Prosthesis Arthrosurface Bone Screws ToeMATE® Hammertoe Correction System HemiCap GRS Glenoid Resurfacing System HemiCAP 7mm MTP Resurfacing HemiCAP Femoral Head Resurfacing HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System CheckMate MTP Arthrodesis System Pinit Small Bone Fusion System HemiCAP(TM) Toe Joint Resurfacing Patello-Femoral Wave (Kahuna) Arthroplasty System HemiCAP Patello-Femoral Resurfacing HemiCAP PFXL Resurfacing System Arthrosurface® Total Toe - Proximal Phalanx Implant UniCAP Knee Resurfacing Prosthesis Wrist Hemiarthroplasty System WristMotion Total Wrist Arthroplasty System KISSloc Suture System HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant BaseCAP AlignMATE Lapidus Arthrodesis System

Establishment Types

Manufacture Medical Device Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility