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.

Quasar-IF

Rasp, 12x14x5mm 8°

Alira Medical Devices

Gubisch Fomon Nasal Rasp

Alexander-Farabeuf Raspatory

Catalogue number 430-396, listed by Sontec Instruments, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Mallory/Head® PF Solid Rasp

4 catalogue numbers from 104451, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Juliet Instrumentation

40° Wedge Rasp, Bayoneted

Versys Femoral Rasp Size 9

Catalogue number SSI005401, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Stille Rasps

RASP FOMON STILLE double-ended TC-inserts 5&6 21.5 cm 8.5 in

iNSitu™ Hip System

Canal Finding Rasp, Dual Taper

Activ L

ACTIV L Curette, diam. 10 mm, round, angled, non-sterile, reusable

Custom Device

W/Slap Hammer EX0521012 Combo Tool

Calix-C Cervical Interbody Spacer

SPECIAL LORDOTIC RASP, 11mm x 14mm x 5mm

GluOn-IF

Rasp, 12x14x5mm 12°

Acis

Acis Endplate Rasp

Endo-Model Knee System – Instruments

Periosteal elevator, reusable - Endo Model Knee System

SL-Plus

Plus SL MIA Curved Rasp 45 DEG

C-Plus™ PEEK VBR/IBF System

Catalogue number 30-C-RASP, listed by Pioneer Surgical Technology, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Pacific Instruments

12x29mm Endplate Rasp, Straight, 449mm OAL

Timberline Lateral Fusion System

Rasp ONE Sided Lateral 14MM

Hayden Medical

Nail & Bone Rasp 6-3/4" (17cm), double ended, backwards cutting

Spinal System

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

L-Box®

Lateral Rasp, Double Sided, 13mmx24mmx5.5mm, Al, Silicone, SST

Tornier Radial Head System

2 catalogue numbers from MTJ018, listed by Tornier Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Mallory/Head Calcar

6 catalogue numbers from 424601, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Rasp

MAKE TO ORDER Tibial Rasp Fine 0 Degree Assembly

Depuy Synthes

Lateral 4MM Straight Rasp

Innesis Peek TL Cage

Catalogue number 52850, listed by BK Meditech Co., Ltd., South Korea, under Rasp. 12 manufacturers in China are registered for this product code.

Revised BIO-Moore Rasp

4 catalogue numbers from 31-482414, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Baby Gorilla®/Gorilla® Plating System

Joint Preparation Rasp, Square, 17mm x 17mm

Enduro

Enduro Rasp F/Trial Tib.stem UP TO D14MM

Osteotomy Instruments

Pyramid Rasp, 12mm

Sq.line

WAGNER SQ.LINE Raspatory, curved, 15 3/4", (400 mm), sharp, rounded blade, ergonomic handle, width: 17 mm, non-sterile, reusable

A-Space Sibd

A-SPACE SIBD Raspatory, 0 °, straight, wide, sharp, non-sterile, reusable

General Instrument

Double Ended Rasp

Allograft – Cervical,construx – Mini Peek VBR

10MM Cervical Rasp

Alamo P, Alamo T

Rasp Instrument, Straight

Skyhawk

Straight Rasp

DJO Surgical

Special, Empowr Balde Stem Lateralized Starter Rasp

Versys Femoral Rasp Size 22

Catalogue number SSI005414, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Bone Raspatory

Bone Raspatory Tungsten Carbide Push TIP Phenolic Handle

Plus

Plus Rasp

InSePtion MIS Fixation System

Rasp, 16 and 18 mm

Versys Femoral Rasp

6 catalogue numbers from SSI005403, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Orthofix

Anatomical Rasp

Liberator

Rasp Liberator Knife II, 4.75 X 149 MM

SpineEx

Rasp Scraper

Cambria NanoMetalene

Cambria NM Rasp

Mallory/Head Cemented Solid Rasp

5 catalogue numbers from 104485, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Kalitec Disc Prep

Rasp, Angled Lumbar

V. Mueller

V. Mueller PUTTI BONE RASP DOUBLE-ENDED, withFLAT TAPERING BLADES, 1 BLADE CURVED ON FLAT OVERALL LENGTH 10-1/2 inches 26.7CM

Columbus Revision

Columbus REV Rasp F/Femur Extension Stem

VerSys Heritage®

3 catalogue numbers from 7892-08-57, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Repositioning Top,

3 catalogue numbers from 78.00.38-36, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Sequoia Pedicle Screw System

2 catalogue numbers from 3252-01, listed by Highridge Medical, LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Rasp

Rasp, 8MM

TiWVE C Cervical Cage System

Cervical rasp, flat, 15mm x 12mm, 10mm, 7 degree, tapered

ActivL

Curette RND Angled Bilat 10MM

Idys™- Alif

Catalogue number 24704000, listed by Clariance, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Alliance Exact

11 catalogue numbers from 31-400110, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Rasp

Bone Rasp 10MM Width

Medline

1675-126-2 Micro-Recp SAW Rasp 47.5MM X

AM

Gastroc Rasp

Rasp

Spinal Rasp Curved 3mm wide, 22cm

Posterior Disc Prep

Rotary Scraper, 12mm

Velofix™ Tlif Cage

4 catalogue numbers from TL0440, listed by CG MedTech Co., Ltd., South Korea, under Rasp. 12 manufacturers in China are registered for this product code.

Versys Femoral Rasp Size 20

Catalogue number SSI005412, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Tranquil-L™

15" Endplate Rasp Str Dbl-Side 7" Handle

Mallory-Head Instrumentation

2 catalogue numbers from 104470, listed by Biomet UK Ltd., United Kingdom, under Rasp. 12 manufacturers in China are registered for this product code.

Mosaic Humeral Rasp

Catalogue number 405042, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Mosaic

8 catalogue numbers from 405043, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Innovasis® Disc Prep

Angled Rasp, Double Sided, SST, Silicone, Al

HIP – Anthology

Catalogue number E0015617-1, listed by Smith & Nephew, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Hermann Medizintechnik GmbH

LAMBOTTE periosteal, 8 1/4" 21cm / 15 mm

C-Box®

12.5 x 11 x 13.5mm Cervical Cage Rasp, SST

Aequalis Reversed II

Metaphyseal Manual Rasp

Gallaher Bone Raspatory

Gallaher Bone Raspatory Concave Curve Blade

TSI

Dual Sided Rasp

Anatomic Access Llif

Anatomic Access LLIF, Rasp, Angled CC-15°, Double Sided

Mallory/Head Cemented

3 catalogue numbers from 104479, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

MaxLock

Straight Polokoff Rasp

Quantum® BacFuse® Spinous Process Fusion Plate

12mm Rasp

Easyspine

4 catalogue numbers from ES952R, listed by Ldr Spine USA, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Complete Cervical Stand Alone IBD

Rasp - 16x14x11mm

Kinectiv®

14 catalogue numbers from 00-7714-007-00, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Autobloquante

8 catalogue numbers from L85931, listed by Depuy (Ireland), Ireland, under Rasp. 12 manufacturers in China are registered for this product code.

BMT Medizintechnik GmbH

Spatula AND Retractor Giessen, 9MM, 16,5

AnyPlus® Cervical PEEK Cage System

Shaver

Rasp

Curette forward angled D 4.5mm, L 7mm, WL 120mm

GEN2

Matson RIB Stripper AND Elevator, Stripper 25MM Wide, Elevator 16MM Wide

BIO-Modular Choice Instruments

9 catalogue numbers from 406777, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Novel

Novel Cervical Rasp, Small 7°LORDOTIC

Curved Femoral Starter Rasp

2 catalogue numbers from 51-222221, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Promos

Promos Stem Rasp 01

Millennium

McCabe Perforation Rasp, rasp on inside of blade, blade angled 120°, 6 1/4" OL, solid square handle

T-Box®

8 catalogue numbers from LCR-02, listed by Inno-Health Technology Co., Ltd., Taiwan, under Rasp. 12 manufacturers in China are registered for this product code.

Exact™

4 catalogue numbers from 31-473795, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

SeaSpine® Spacer System – Redondo

Redondo Rasp, 26mm x 24mm x 16mm, 5 Deg Lordotic

Legion

Tibial Rasp Handle Assembly

Raspatory With Blue Plastic Handle Slightly Curved Round Blade 6 Mm 18.5 Cm

Catalogue number 29.04.06-S, listed by Accuratus AG, Switzerland, under Rasp. 12 manufacturers in China are registered for this product code.

Intervertebral Body Fusion Device

Rasp Curved Serrated

Parallel Rasp 14mm

Catalogue number FCI0300, listed by Captiva Spine, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Grooved Raspatory

Grooved Raspatory Medium Grit Curved TIP Diamond Coated

Dissector, Dura, Acc. Penfield Fig. 2 19.5cm

Catalogue number 28-0042, listed by Geister Medizintechnik Gmbh, Germany, under Rasp. 12 manufacturers in China are registered for this product code.

IntraBlock™ TwinStem™

IntraBlock TwinStem Rasp Size 10.00 non-sterile

Impix-Alif S/A

Impix Alif S/A Rasp Medium

Solus

Solus Straight Rasp

Aequalis Fracture

Cylindrical Reamer

Flexible Pusher Tip and Set Screw

Catalogue number 3D-T01-07, listed by Surgentec LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Exact(TM)

3 catalogue numbers from 31-473796, listed by Biomet Orthopedics, United States, under Rasp. 12 manufacturers in China are registered for this product code.

Polokoff Bone Raspatory

Polokoff Bone Raspatory Double Ended Single-Sided TIP

CPT®

6 catalogue numbers from 31-8334-02-02, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

C-Thru Anterior Spinal Spacer System

11MM Parallel Rasp (14MM Wide)

Nvc

Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)

Decortication Rasp- Straight

2 catalogue numbers from 3D-D05-04, listed by Surgentec LLC, United States, under Rasp. 12 manufacturers in China are registered for this product code.

X-Box

Catalogue number LCR-01, listed by Inno-Health Technology Co., Ltd., Taiwan, under Rasp. 12 manufacturers in China are registered for this product code.

Endoskeleton® TA VBR

7 Deg Lordotic, Rasp, Standard, 20mm

Brasseler USA

10 catalogue numbers from KM5100-37-113, listed by Provision, under Rasp. 12 manufacturers in China are registered for this product code.

Trabecular Metal®

12 catalogue numbers from 00-7865-009-00, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Alloclassic®

13 catalogue numbers from 6824, listed by Zimmer, Inc., United States, under Rasp. 12 manufacturers in China are registered for this product code.

Advantage C Cervical Interbody Fusion Device

Advantage C, Small Rasp

Apex Knee System

EVO Punch Dart w additional cement mantle sz 5-6

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