Suture, Nonabsorbable, Synthetic, Polyethylene

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Shandong, Shanghai and Beijing, and 1 other province: 6 hold an FDA registration.

ARC Medical Supplies (Beijing) Co., Ltd. Beijing
Arthrex (Shanghai) Co., Ltd. Shanghai
Foosin Medical Supplies Inc.ltd Shandong
Shandong Haidike Medical Products Co., Ltd. Shandong
Xiamen Zhiyuan Medical Technology Co., Ltd. Fujian, contract manufacturer
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is GAT Classified?

Suture, Nonabsorbable, Synthetic, Polyethylene is FDA product code GAT, Class 2, 21 CFR 878.5000.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 140 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 23 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Employee error (8), Packaging process control (4) and Device Design (4).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Suture, Nonabsorbable, Synthetic, Polyethylene

Hr26 2-0 Ctd Wht Brdpvn 30″/75

Catalogue number E823N, listed by Surgical Specialties México, S. de R.L. de C.V., under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

SuperBall

The SuperBall Meniscal Repair System is a single patient, single use, an all-inside, all-suture meniscal repair device.

Suture, Nonabsorbable, Synthetic, Polyethylene

BroadBand Suture

Catalogue number 110045768, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

CrossFix®

CrossFix® All-Suture Meniscal Repair, straight

Suture, Nonabsorbable, Synthetic, Polyethylene

BroadBand Meniscal Needles

Catalogue number CM-0307N, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

PilotGraft BTB Tendon, 11 Mm

PilotGraft BTB Tendon, 11 mm: 1 catalogue number listed by Joint Restoration Foundation Inc, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Lariat

Lariat: 1 catalogue number listed by Atricure, Inc., United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

QuickGraft

QuickGraft Pre-Sutured Tendon

Suture, Nonabsorbable, Synthetic, Polyethylene

Hrt17 3-0 Grn Brd Pvn 12″ Loop

Catalogue number FC-2678N, listed by Surgical Specialties México, S. de R.L. de C.V., under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

JRF VersaGraft

JRF VersaGraft: 1 catalogue number listed by Joint Restoration Foundation Inc, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

HS Fibr

Catalogue number NSP-HS336, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Riverpoint Brachytherapy

Catalogue number HS-2/0C-BB, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Maxbraid™

Catalogue number 900337, listed by Biomet Orthopedics, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

ACE Surgical Poly Gr 5-0 18″ Hrt17

003-2500 Poly Gr 5-0 18" Hrt17

Suture, Nonabsorbable, Synthetic, Polyethylene

Menix

MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed of one anchor pre-tied with a suture.

Suture, Nonabsorbable, Synthetic, Polyethylene

Fastloop™ White

Polyester Suture Loop White with Needle

Suture, Nonabsorbable, Synthetic, Polyethylene

Stopper S-PI-A3.0

Stopper for Ultrasonic Handpiece for SF Push-in Anchor 3.0

Suture, Nonabsorbable, Synthetic, Polyethylene

Uniester

Braided, Polyester Synthetic non-absorbable Surgical Sututres / Ligatures

Suture, Nonabsorbable, Synthetic, Polyethylene

Tenoflex

White Braided Polyethylene Size 2-0 20" T-2 Needle Capere

Suture, Nonabsorbable, Synthetic, Polyethylene

Ds19 4-0 Wht Brd Pvn 18″/45cm

Catalogue number F633N, listed by Surgical Specialties México, S. de R.L. de C.V., under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

SofTIP

A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic…

Suture, Nonabsorbable, Synthetic, Polyethylene

Xclose Plus

Tissue Repair System With Invisiloc Technology

Suture, Nonabsorbable, Synthetic, Polyethylene

HiFi Ribbon

Catalogue number HR713WN, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Guide S-PI / W5.0

Drill Guide for SF Push-in Anchor Portfolio Integrated Wrench 5.0

Suture, Nonabsorbable, Synthetic, Polyethylene

SonicAnchor

Catalogue number 1910-1252S, listed by Stryker GmbH, Switzerland, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Dafilon

Dafilon Blue 2 (5) 150CM HR65

Suture, Nonabsorbable, Synthetic, Polyethylene

Stryker AIR™

Stryker AIR™ All-Inside Meniscal Repair

Suture, Nonabsorbable, Synthetic, Polyethylene

Arthro Vlink Suture Loop

Catalogue number HS1042, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Suture Loop

Catalogue number HS1063, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Stopper S-PI-A1.6

Stopper for Ultrasonic Handpiece for SF Push-in Anchor 1.6

Suture, Nonabsorbable, Synthetic, Polyethylene

Hrt17 4-0 Grn Brd Pvn 12″ Loop

Catalogue number FC-2600N, listed by Surgical Specialties México, S. de R.L. de C.V., under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Drill S-PI-A2.3

Drill for SF Push-in Anchor 2.3

Suture, Nonabsorbable, Synthetic, Polyethylene

L-1180B

Salvin 4-0 Polyviolene Green C6 Needle 18"(45CM)

Suture, Nonabsorbable, Synthetic, Polyethylene

Powertape

2 catalogue numbers from TAPRPBB001, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Meniscus Versaflex

2 catalogue numbers from Meniscus Versaflex - Reverse, listed by GM DOS Reis Industria E Comercio Ltda, Brazil, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Suture, Nonabsorbable, Synthetic, Polyethylene

Secure-Lock

Catalogue number 102-1377, listed by Xiros Ltd, United Kingdom, under Suture, Nonabsorbable, Synthetic, Polyethylene. 6 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer