Rasp

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Shanghai, Guangdong and Jiangsu, and 2 other provinces: 12 hold an FDA registration. 4 are contract manufacturers.

Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
B.Braun Medical (Suzhou) Co,.Ltd Jiangsu, contract manufacturer
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Jiangsu, contract manufacturer
Guangzhou Aquila Precise Tools Limited Guangdong, contract manufacturer
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
MicroPort Orthopedics Global Supply Center Limited Shanghai, contract manufacturer
Shanghai Lions Industrial Co., Ltd. Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Shanghai Jolly Industrial Co., Ltd. Shanghai, contract manufacturer
Shenzhen Xiazhifeng Electronic Co., Ltd. Guangdong, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code HTR?

Rasp is FDA product code HTR, Class 1, 21 CFR 878.4800.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2008. None was by a company in China. The root cause the FDA records most often is Packaging process control (2).

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

X-PAC

Rasp, Double-Sided, Straight

NexGen®

Catalogue number 5881-51, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Decortication Rasp – Curved

Catalogue number 3D-D05-05, listed by Surgentec LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

ForeFoot STP

Polokoff Rasp

Stable-L™

Stable-L Rasp

CeMend Cemet Mold Rasp

Catalogue number AR-902-11, listed by G21 SRL, under Rasp. 12 manufacturers in China are registered for this product code.

Fusion™ Anterior Instrument Set

Rasp, Angled

My Medical

Rhinoplasty Rasp, Straight

Dental Rasp

Dental Rasp #2 Tungsten Carbide Serrated

Compressor, Vessel 35cm 4cm Wide

Catalogue number 03-6560, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

Dxtend HUM Broach DIA 16 MM

Catalogue number 2307-89-016, listed by Enztec Limited, New Zealand, under Rasp. 12 manufacturers in China are registered for this product code.

ConMed

Catalogue number 5080-007, listed by Provision, under Rasp. 12 manufacturers in China are registered for this product code.

Hips-Misc

Catalogue number E0016345-1, listed by Smith & Nephew, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Hakansson Rongeur

Hakansson Rongeur Curved TIP

Salto Talaris®

Rasp, Tibial Flange

Ergonomic Handle

Ergonomic Handle With Interchangeable Heads

Arthroscopic Rasp

Arthroscopic Rasp Universal Handle Short 15 Degree Angle 4 X 6 Millimeters Tip

Versys Femoral Rasp Size 19

Catalogue number SSI005411, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

P.F.C.

P.F.C. Femoral Rasp

Lospa IS Spinal System

Bone Rasp, Straight

Zimmer

Rasp/Scraper

Reclaim

Reclaim Finishing Rasp

Prelude PF Rasp

Catalogue number 110007398, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Anterior Disc Prep

Single Sided Rasp

Lonestar

17mm W x 13mm L x 12mm H, 7° LORDOTIC RASP

Rasp

Catalogue number E0015089-1, listed by Smith & Nephew, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

PathFinder NXT Minimally Invasive Pedicle Screw System

Pedicle Access Tool Offset Rasp

Neuflex

Neuflex MCP Rasp/AWL

Kmedic

Bone Rasp Number 64 7" 3&4 Millimeter

Rasp

Thompson Rasp

Oracle

Oracle Rasp

Versys Femoral Rasp Size 21

Catalogue number SSI005413, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Combination Bone Raspatory

Combination Bone Raspatory Putti Leaflet TIP

Xsert Lumbar Expandable Interbody System

Catalogue number T092-0700, listed by Xtant Medical Holdings, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

GraftRasp Teeth and Set Screw – Bladed

Catalogue number 3D-D05-07, listed by Surgentec LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Dxtend HUM Broach DIA 10 MM

Catalogue number 2307-89-010, listed by Enztec Limited, New Zealand, under Rasp. 12 manufacturers in China are registered for this product code.

TLS 5.0

Rasp, Straight, 5mm X 8mm

Tightening ROD

Catalogue number 1100-4854, listed by Sontec Instruments, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Gill

G-99 Nail Rasp Double-Ended

Identity 40MM Inset Humeral Protector

Catalogue number SSI008489, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Synthes

Catalogue number 03.000.361, listed by Provision, under Rasp. 12 manufacturers in China are registered for this product code.

TiWAVE C Cervical Cage Sytem

Cervical rasp, flat, 13mm x 12mm, 12mm, 7 degree, tapered

Combination Bone Rasp SET

Combination Bone Rasp SET With Interchangeable Heads Ergonomic Handle

Pilling

Catalogue number IPN002223, listed by Teleflex Medical LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Elemax® Cortical Spacer

Catalogue number 30-CS-RASP, listed by Xtant Medical Holdings, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Vital Spinal Fixation System

Catalogue number 738M1101, listed by Highridge Medical, LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Honey Badger Rasp

Catalogue number 110030227, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Annex® 2 Adjacent Level System

Open-Ended Rasp

A-Box®

Lumbar Rasp Assembly, Ti 6Al 4V, SST

Ochsner Dissector 3mm/4mm 18cm W/o Hole

Catalogue number 28-0088.GE1, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

Dissector, Intima, Acc. Robb 4/2.0mm 24cm

Catalogue number 28-0031.04, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

Rasp

Diamond Cannal Rasp Innomed

Raspatory Wagner With Blue Plastic-Handle 8 Mm 33 Cm

Catalogue number 29.20.20, listed by Accuratus AG, Switzerland, under Rasp. 12 manufacturers in China are registered for this product code.

Atec Biologics

Univeral Allograft Rasp

TheRay Collared and Collarless Femoral Stem

Canal Finding Rasp, Collared Stem

Fusion™ Posterior Instrument Set

2 catalogue numbers from 30-RASP-S, listed by Xtant Medical Holdings, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Mergence-A Preparation Instrumentation

Rasp, Anterior

Illico FS

Facet Rasp

Custom

IMPIX-C RASP 12.5mm x 14mm

Howard Bone Raspatory

Howard Bone Raspatory Double Ended Single-Sided JAW #12CA

Decortication Rasp – Fixed Curved

Catalogue number 3D-D05-03, listed by Surgentec LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Polar

Rasp With Polar Cutting Teeth

Endoskeleton® TC

6 Deg Lordotic Rasp Assembly, Small

Spira-A

Rasp, Straight, Double-Sided, 10.5mm Tip, 17", 8" Silicone Handle, DLC Coating

Humeris Shoulder

Rasp Size 20

Spine Wave Instruments

Rasp, Dual-Sided, Straight

M/L Taper Starter Rasp

Catalogue number SSI006592, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Dxtend HUM Broach DIA 12 MM

Catalogue number 2307-89-012, listed by Enztec Limited, New Zealand, under Rasp. 12 manufacturers in China are registered for this product code.

Maltz Raspatory

Maltz Raspatory Double Ended Single Sided TIP UP/Down Rasping

Mariner Outrigger

Catalogue number 99-0006, listed by Seaspine Orthopedics Corporation, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Combination Bone Rasp

Combination Bone Rasp Flat Round TIP

NEO Ic™peek Lumbar Cage

3 catalogue numbers from CL0508, listed by CG MedTech Co., Ltd., South Korea, under Rasp. 12 manufacturers in China are registered for this product code.

Disc Preparation Instruments

Catalogue number 138M1101, listed by Highridge Medical, LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

TAP-LIF Instruments

Bent Rasp

Meniscus Allograft Transplantation (MAT)

Rasp 7mm

Weitlaner Mouth Spreader

Weitlaner Mouth Spreader Fenestrated Blades

Ergoplant

BUSER ERGOPLANT Raspatory, 7", (180 mm), double ended, non-sterile, reusable

Pisces-SA

Double-Sided Rasp

Taperloc Exact Instrumentation

Catalogue number 31-103215, listed by Biomet UK Ltd., United Kingdom, under Rasp. 12 manufacturers in China are registered for this product code.

CD Horizon® Spinal System

Rasp 6630914 Parallel 5MMX15MMX12MM

MD Vue Discectomy

Rasp - 6mm

Dissector, Intima, Acc. Robb 3/1.5mm 24cm

Catalogue number 28-0031.03, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

Rasp

Rasp - Short

Mallory/Head PF Rasp/Provisional

Catalogue number 104476, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Scarlet AL-T Instrumentation

Rasp, Straight, 14MM

Connector

Curved Rasp

Ochsner Dissector 1mm/2mm 18cm W/o Hole

Catalogue number 28-0087.GE1, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

GraftRasp Teeth and Set Screw – Curved

Catalogue number 3D-D05-01, listed by Surgentec LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Intuition

Intuition FOR HP Partial Tibial Keel Rasp

Dissector, Dura, Acc. Penfield Fig. 1 17.5cm

Catalogue number 28-0041, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

Fusion™ Anterior Instrument Set

Catalogue number 34-RASP-S, listed by Xtant Medical Holdings, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Vu a-POD

Catalogue number 21-40-0120, listed by Seaspine Orthopedics Corporation, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Spark – Instruments

Bone file/rasp, manual - General Instrument

Velofix™ PEEK Lumbar Cage

3 catalogue numbers from PL0440, listed by CG MedTech Co., Ltd., South Korea, under Rasp. 12 manufacturers in China are registered for this product code.

GraftRasp Teeth and Set Screw- Straight

Catalogue number 3D-D05-06, listed by Surgentec LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Regatta Lateral System

Angled Dual Sided Rasp

Dissector, Dura, Acc. Penfield Fig. 5 29cm

Catalogue number 28-0045, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

Vitality®

Catalogue number 730M1003, listed by Biomet Spine, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Rasp

MODIFIED INSTRUMENT RASP, 10mm

Elevator, Vessel, Acc. Freer 20cm

Catalogue number 28-0071, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

Versys Femoral Rasp Size 17

Catalogue number SSI005409, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Surgical Instrument

2 catalogue numbers from 111-298, listed by Jeil Medical Corporation, South Korea, under Rasp. 12 manufacturers in China are registered for this product code.

Reprocessed Small Tear Cross Cut Rasp, 11mm X 5mm

Catalogue number 5100-37-113, listed by Suretek Medical, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Raspatory Straight With Conical Lap and Round Blade 20 Mm 24 Cm

Catalogue number 29.11.22, listed by Accuratus AG, Switzerland, under Rasp. 12 manufacturers in China are registered for this product code.

Salto Talaris Total Ankle Prosthesis

Catalogue number MJU350T, listed by Smith & Nephew, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

KeyLift™

10mm Rasp Trial

Herbert/Whipple®

Catalogue number 1154-77, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Alliance

10 catalogue numbers from SSI004733, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

FuzeFix Chamfered Screws

Manual Rasp Mirror

Attune

Attune Rasp

Dissector, Acc. Olivecrona, Del. 18.5cm

Catalogue number 28-0080, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

Avenir Complete Shark Tooth Rasp Full/W Reduced Cut

Catalogue number SSI005937, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

InterBRIDGE

2 catalogue numbers from IB9022R, listed by Ldr Spine USA, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Brasseler

2 catalogue numbers from KM-82, listed by Provision, under Rasp. 12 manufacturers in China are registered for this product code.

Integral Femoral Rasp

Catalogue number 31-473619, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Dissector, Dura, Acc. Penfield Fig. 4 20.5cm

Catalogue number 28-0044, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

Expanding Innovations

Bayonet Triangle Curette, 45 Deg Up

Bone Graft Funnel

Catalogue number 3D-F05-01, listed by Surgentec LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Viant Medical, LLC

DELTA XTEND™ Humeral Rasp 16 mm

TiWAVE C Cervical Cage Sysem

Cervical rasp, flat, 13mm x 12mm, 5mm, 7 degree, tapered

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