Orthomed

Stardrive Screwdriver Shaft T15 QC Self-Retain 100

Registry build 21.09.26
1manufacturer
37catalogue 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 Orthomed
Listed by Ortho-MED, Inc., United States
FDA product code LRZ
Device type Screwdriver, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2026-07-14

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Orthomed
Catalogue number Size Status
OM 48-0350 In distribution
OM 48-0670 In distribution
OM 48-0484 In distribution
OM 47-0954 In distribution
OM 48-0364 In distribution
OM 47-0951 In distribution
OM 48-0358 In distribution
OM 48-0481 In distribution
OM 48-0349 In distribution
OM 48-0485 In distribution
OM 47-0958 In distribution
OM 48-0355 In distribution
OM 48-0352 In distribution
OM 48-0354 In distribution
OM 48-0474 In distribution
OM 48-0362 In distribution
OM SYN314116 In distribution
OM 47-0956 In distribution
OM 48-0476 In distribution
OM 48-0368 In distribution
OM 48-0480 In distribution
OM 48-0348 In distribution
OM SYN314119 In distribution
OM 48-0360 In distribution
OM 47-0961 In distribution
OM 48-0479 In distribution
OM 48-0477 In distribution
OM 48-0487 In distribution
OM 48-0486 In distribution
OM 45-0004 In distribution
OM 48-0475 In distribution
OM 48-0490 In distribution
OM 47-0953 In distribution
OM 48-0353 In distribution
OM SYN314467 In distribution
OM 48-0356 In distribution
OM 48-0489 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bioplate® Bioplate, Inc. 46
Faico CMF System Faico Medical, LLC 40
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