Bioplate®

Short Screwdriver Blade - Cross Drive - Handle (B)

Registry build 21.09.26
1manufacturer
46catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LRZ
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62

Record

Regulatory record for Bioplate®
Listed by Bioplate, Inc., United States
FDA product code LRZ
Device type Screwdriver, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-10-23
Record revised 2025-06-09 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
Sizes Length 1.7 to 6.5 in; length 6.5 mm

Catalogue Numbers

Catalogue numbers for Bioplate®
Catalogue number Size Status
81-3107 Length 4.02 in In distribution
81-3107-CP Length 4.02 in In distribution
81-7462-CP Length 1.70 in In distribution
81-3405 Length 3.93 in In distribution
81-5750 Length 2.82 in In distribution
81-3101 Length 3.15 in In distribution
81-3312 Length 2.25 in In distribution
81-2034-CP Length 2.95 in In distribution
81-2021 Length 6 in In distribution
ASB8-25 Length 2.56 in In distribution
ASHA-24 Length 6.4 in In distribution
81-3310 Length 2.25 in In distribution
81-3361 Length 2.96 in In distribution
81-3340 In distribution
81-3103-CP Length 3.40 in In distribution
81-5750-CP Length 2.82 in In distribution
81-3342 In distribution
ASB2-20 Length 2.95 in In distribution
81-3367 In distribution
ASHA-22 Length 6.0 in In distribution
81-3197 Length 3.93 in In distribution
81-3111 Length 4.125 in In distribution
ASB2-45 Length 3.15 in In distribution
81-7460 Length 1.70 in In distribution
81-2027-CP Length 2.95 in In distribution
81-3111-CP Length 4.125 in In distribution
ASHB-45 Length 4.125 in In distribution
81-2027 Length 2.95 in In distribution
81-5751-CP Length 2.82 in In distribution
ASB2-40 Length 3.2 in In distribution
81-3102 Length 6.5 mm In distribution
ASB2-20-SALE Length 2.95 in In distribution
81-7461 Length 1.70 in In distribution
81-7462 Length 1.70 in In distribution
81-5751 Length 2.82 in In distribution
ASHB-44 Length 6.5 in In distribution
ASHB-42 Length 6.25 in In distribution
81-3103 Length 3.40 in In distribution
81-3364 In distribution
ASB2-40-SALE Length 3.2 in In distribution
ASHA-25 Length 4.0 in In distribution
81-3100 Length 6.25 in In distribution
81-3046 Length 6.4 in In distribution
ASB8-25-SALE Length 2.56 in In distribution
81-2034 Length 2.95 in In distribution
81-7461 Length 1.70 in In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Faico CMF System Faico Medical, LLC 40
Orthomed Ortho-MED, Inc. 37
Dental Instrument Cowellmedi Co., Ltd. 26
A.l.p.s. mvX™ Tyber Medical 12
Titanex Vilex LLC 9
Torque Shank I.T.S. Gmbh 5
Hexagon-Shank I.T.S. Gmbh 5
Leos Cannulated Screw System Tyber Medical 5
Screw Driver I.T.S. Gmbh 4
Screwdriver Shank I.T.S. Gmbh 4
Dynex Vilex LLC 4
Lsss Lockdown Medical Limited 2

Showing 12 of 32. All products under Screwdriver, Surgical

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