Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014967149

FEI Number

3014967149

Entity Name

GLW, Inc.

City/State/Country

Englewood Cliffs, NJ, US

Establishment Address

930 Sylvan Ave Ste 125, Englewood Cliffs, NJ 07632, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

GLW, INC. (Owner Number: 10058309)

Owner / Operator Contact Address

930 Sylvan Ave, Suite 125, Englewood Cliffs, NJ 07632, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

T6-0300-050 ARTEMIS 5 locking screw 50mm, fully threaded T6-0300-035 ARTEMIS 5 locking screw 35mm, fully threaded T6-0300-100 ARTEMIS 5 locking screw 100mm, fully threaded T6-0300-047 ARTEMIS 5 locking screw 47.5mm, fully threaded T5-0210-000 Targeting Device T6-0200-110 ARTEMIS 11 lag screw, 110mm T6-0200-105 ARTEMIS 11 lag screw, 105mm T6-0200-080 ARTEMIS 11 lag screw, 80mm T6-0200-095 ARTEMIS 11 lag screw, 95mm T6-0300-070 ARTEMIS 5 locking screw 70mm, fully threaded T6-0200-090 ARTEMIS 11 lag screw, 90mm T6-0300-090 ARTEMIS 5 locking screw 90mm, fully threaded T6-0300-030 ARTEMIS 5 locking screw 30mm, fully threaded T6-0200-097 ARTEMIS 11 lag screw, 97.5mm T6-0200-130 ARTEMIS 11 lag screw, 130mm T6-0300-065 ARTEMIS 5 locking screw 65mm, fully threaded T6-0200-100 ARTEMIS 11 lag screw, 100mm T6-0200-092 ARTEMIS 11 lag screw, 92.5mm T6-0200-070 ARTEMIS 11 lag screw, 70mm T6-0180-110S ARTEMIS proximal femoral nail 11x180mm, short kit with pre-loaded set screw T6-0300-055 ARTEMIS 5 locking screw 55mm, fully threaded T6-0300-105 ARTEMIS 5 locking screw 105mm, fully threaded T6-0300-075 ARTEMIS 5 locking screw 75mm, fully threaded T6-0300-045 ARTEMIS 5 locking screw 45mm, fully threaded T6-0200-075 ARTEMIS 11 lag screw, 75mm T6-0200-120 ARTEMIS 11 lag screw, 120mm T6-0300-080 ARTEMIS 5 locking screw 80mm, fully threaded T6-0300-110 ARTEMIS 5 locking screw 110mm, fully threaded T6-0300-060 ARTEMIS 5 locking screw 60mm, fully threaded T6-0300-032 ARTEMIS 5 locking screw 32.5mm, fully threaded T6-0300-095 ARTEMIS 5 locking screw 95mm, fully threaded T6-0300-085 ARTEMIS 5 locking screw 85mm, fully threaded T6-0300-040 ARTEMIS 5 locking screw 40mm, fully threaded T6-0300-027 ARTEMIS 5 locking screw 27.5mm, fully threaded T6-0200-102 ARTEMIS 11 lag screw, 102.5mm T6-0300-037 ARTEMIS 5 locking screw 37.5mm, fully threaded T6-0200-125 ARTEMIS 11 lag screw, 125mm T6-0300-042 ARTEMIS 5 locking screw 42.5mm, fully threaded T6-0200-115 ARTEMIS 11 lag screw, 115mm T6-0300-025 ARTEMIS 5 locking screw 25mm, fully threaded T6-0200-085 ARTEMIS 11 lag screw, 85mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 48mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 60mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 100mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 120mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 95mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 32mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 60mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 90mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 20mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 12mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 46mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 100mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 32mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 18mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 26mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 55mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 46mm CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 22mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 60mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 65mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 42mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 75mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 85mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 60mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 20mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 44mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 60mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 46mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 46mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 95mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 105mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 34mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 46mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 48mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 26mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 50mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 28mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 20mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 50mm CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 24mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 36mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 60mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 65mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 30mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 60mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 70mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 38mm CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 20mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 80mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 44mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 40mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 46mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 28mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 65mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 110mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 55mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 85mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 110mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 90mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 22mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 70mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 120mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 85mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 40mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 75mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 75mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 100mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 60mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 36mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 24mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 32mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 65mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 70mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 50mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 30mm CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 14mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 115mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 24mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 80mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 46mm CREED Cannulated Screws / Washer 4.3mm / OD 7.5mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 42mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 40mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 14mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 65mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 55mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 44mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 44mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 44mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 48mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 80mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 48mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 55mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 36mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 55mm CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 30mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 55mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 40mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 46mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 55mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 80mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 30mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 40mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 48mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 80mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 70mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 75mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 75mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 95mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 50mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 60mm CREED Cannulated Screws / Washer 5.6mm / OD 11mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 46mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 115mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 120mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 65mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 95mm CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 16mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 48mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 46mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 70mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 90mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 80mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 50mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 38mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 48mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 50mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 30mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 50mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 75mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 42mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 105mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 115mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 55mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 24mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 44mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 55mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 34mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 18mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 28mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 75mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 5.6 x 44mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 110mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 115mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 65mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 26mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 42mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 110mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 42mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 50mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 105mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 65mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 40mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 60mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 120mm CREED Cannulated Screws / Headed / Thread 32mm / 5.6 x 70mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 105mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 16mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 34mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 70mm CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 18mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 90mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 80mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 55mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 44mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 40mm CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 26mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 100mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 80mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 42mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 42mm CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 28mm CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 48mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 34mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 42mm CREED Cannulated Screws / Headed / thread 8mm / 2.5 x 22mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 30mm CREED Cannulated Screws / Washer 7.4mm / OD 13mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 44mm CREED Cannulated Screws / Headless Compression / Thread 16mm / 5.6 x 36mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 75mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 48mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 18mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 38mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 50mm CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 85mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 42mm CREED Cannulated Screws / Washer 2.5mm / OD 5mm CREED Cannulated Screws / Headless Compression / Thread 19mm / 7.4 x 50mm CREED Cannulated Screws / Headless Compression / Thread 10mm / 4.3 x 48mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 38mm CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 70mm CREED Cannulated Screws / Headed / Thread 16mm / 5.6 x 32mm CREED Cannulated Screws / Headed / Thread 10mm / 4.3 x 22mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-03-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-02-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-02-22
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2022-03-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-02-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-02-15
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2025-03-26
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2022-03-02
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2020-12-01
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2023-09-14
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-09-23
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-09-22
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2022-03-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-12-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-04-06
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-03-17

Official Correspondent

Arundhati Radhakrishnan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GLW, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014967149. Last updated year: 2026. Please use registration number 3014967149 when referencing this establishment in official correspondence.