Who else makes this device?

Name: V-TEK™
Brand: V-TEK™

V-TEK™

15 catalogue numbers from 28.65.024, listed by Zimmer, Inc., United States, under Washer, Bolt Nut. 9 manufacturers in China are registered for this product code.

Registry build 21.09.26

9manufacturers in China registered for this device type

15catalogue numbers in this listing

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTN
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	17
Suzhou Kangli Orthopaedics Instrument Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	11
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38
Suzhou Endophix Co., Ltd.	Suzhou	Jiangsu	Manufacturer	17

Record

Regulatory record for V-TEK™
Listed by	Zimmer, Inc., United States
FDA product code	HTN
Device type	Washer, Bolt Nut
Device class	Class 2
Regulation	21 CFR 888.3030
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K151708
Record published	2016-12-30
Record revised	2024-02-19 (version 4)

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
Sizes	Outer diameter 2 to 3 mm; length 8 to 36 mm
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for V-TEK™
Catalogue number	Size	Status
28.65.024	TX6	In distribution
28.65.020	TX6	In distribution
28.65.108	Outer Diameter 2 mm	In distribution
28.65.036	TX6	In distribution
28.65.032	Length 32 mm	In distribution
28.65.122	Outer Diameter 2 mm	In distribution
28.65.018	Length 18 mm	In distribution
28.65.028	TX6	In distribution
28.65.128	Outer Diameter 2 mm	In distribution
28.65.034	TX6	In distribution
28.65.126	TX6	In distribution
28.65.014	TX6	In distribution
28.65.030	TX6	In distribution
28.65.130	Outer Diameter 2 mm	In distribution
28.65.124	TX6	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Washer, Bolt Nut	Zimmer, Inc.	308
MaxTorque™	Tornier Inc.	171
Arthrex®	Arthrex, Inc.	154
Kyocera Medical Technologies, Inc.	Kyocera Medical Technologies, Inc.	92
Washer, Bolt Nut	Synthes Gmbh	88
A.l.p.s.®	Biomet Orthopedics	67
Variax	Stryker GmbH	59
Conmed	ConMed Corporation	38
Neoortho	Neoortho Produtos Ortopédicos S/A	32
Aptus	Medartis Inc.	31
AC Device	Lockdown Medical Limited	31
Evos	Smith & Nephew, Inc.	28

Showing 12 of 304. All products under Washer, Bolt Nut

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K091799	2009-09-11

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2019-10-10	Class II	Packaging change control	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).	5459583 total devices	2020-05-19

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.