Tap, Bone

APERTURE SPINAL ACCESS SYSTEM TAP, CANNULATED 5.5mm 30-60mm Plus or Minus 1.00 Percent

Registry build 21.09.26
12manufacturers in China registered for this device type
248catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWX
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Changzhou Xietong Industries Co., Ltd. Changzhou Jiangsu Exporter 11
Changzhou Centrau Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 9

Record

Regulatory record for Tap, Bone
Listed by Depuy Spine, Inc., United States
FDA product code HWX
Device type Tap, Bone
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2017-11-17
Record revised 2022-12-08 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2019-02-28

Catalogue Numbers

Catalogue numbers for Tap, Bone
Catalogue number Size Status
698342473 In distribution
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Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 429
Mariner Seaspine Orthopedics Corporation 285
Tap, Bone Medtronic Sofamor Danek, Inc. 228
Tap, Bone Synthes Gmbh 191
Invictus Alphatec Spine, Inc. 129
Specials Seaspine Orthopedics Corporation 99
Arsenal Alphatec Spine, Inc. 82
Generic Surgical Instruments CTL Medical Corporation 81
Mariner MIS Seaspine Orthopedics Corporation 78
Vital Spinal Fixation System Highridge Medical, LLC 72
Custom Medicrea International 68
Anax 5.5™ Spinal System CG MedTech Co., Ltd. 65

Showing 12 of 545. All products under Tap, Bone

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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