FDA.reportPublic FDA data

Screwdriver

Primary DI
00810111224987
Brand
Screwdriver
Company
Treace Medical Concepts, Inc.
Model
02-00440
Device description
3.5mm VPCS SCREWDRIVER, NON-CANNULATED
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111224987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111224987008101112249878101112249870810111224987

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054808082
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111223706Positioner02-004792026-08-17
00810111225465joint seeker02-004602026-08-17
00810111225427Targeter02-004772026-08-14
00810111225434Targeter02-004762026-08-14
00810111228374Positioner / Compressor02-005792026-07-17
00810111228381Positioner / Compressor02-005782026-07-17
00810111227353ScalpelSN562026-06-05
00810111227292K-Wire02-005432026-06-02
00810111227346Scalpel 02-003872026-05-19
00810111227223SpeedMTP SelectSK692026-05-13
00810111227247SpeedMTP SelectSD342026-05-13
00810111227254SpeedMTP SelectSD332026-05-13
00810111225663X-ray App12-000012026-05-01
00810111226769ReamerSN502026-05-01
00810111226776ReamerSN512026-05-01
00810111226783ReamerSN522026-05-01
00810111227261K-Wire02-005202026-04-27
00810111225007Screwdriver02-004422026-04-15
00810111225021Screwdriver02-004442026-04-15
00810111225069Screwdriver02-004482026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982096274ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158620ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158675ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158729ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158774ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158828ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167615ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167660ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167714ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167769ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167813ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167868ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167912ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167967ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168018ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168063ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168117ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175740ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175795ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14