Pass LP

CANNULATED CONICAL TAP FOR DUAL LEAD SCREW Ø5.5 mm

Registry build 21.09.26
12manufacturers in China registered for this device type
38catalogue 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 Pass LP
Listed by Medicrea International, France
FDA product code HWX
Device type Tap, Bone
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2017-02-03
Record revised 2023-03-20 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2023-03-24
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Pass LP
Catalogue number Size Status
A02317510 In distribution
A02315510 In distribution
A02314510 In distribution
A02316510 In distribution
A02116520 Withdrawn
MS239 Withdrawn
A02114520 Withdrawn
A02116510 Withdrawn
A01117200 Withdrawn
A02117500 Withdrawn
A02219500 Withdrawn
A02117520 Withdrawn
MS237 Withdrawn
A02214500 Withdrawn
A02117530 Withdrawn
A02116530 Withdrawn
A02115520 Withdrawn
MS240 Withdrawn
A02216500 Withdrawn
A02115010 Withdrawn
A01115500 Withdrawn
A02118530 Withdrawn
A01114500 Withdrawn
A02115020 Withdrawn
A02115510 Withdrawn
A02318510 Withdrawn
A02315010 Withdrawn
A01116500 Withdrawn
A02118520 Withdrawn
A02115530 Withdrawn
A02217500 Withdrawn
A02115030 Withdrawn
A02215500 Withdrawn
A02319510 Withdrawn
MS238 Withdrawn
A02114530 Withdrawn
A02218500 Withdrawn
A02117510 Withdrawn

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 Depuy Spine, Inc. 248
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

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