FDA.reportPublic FDA data

Signex

Primary DI
08800071023319
Brand
Signex
Company
OSTEONIC CO.,Ltd.
Model
S3B.50800
Published
2025-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230546000SIGNEXOsteonic Co., Ltd.2024-06-11HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800071023319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800071023319088000710233198800071023319

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688999370
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800071055471ASTERN3A.202302026-05-18
08800071055457ASTERN3A.201902026-04-27
08800071055464ASTERN3A.202102026-04-27
08800071055440ASTERN3A.201702026-03-19
08809416064703SignexA2C.080702025-06-24
08809416064802SignexA1R.080102025-06-24
08809416065267SignexA2A.100502025-06-24
08809416065274SignexA2A.100802025-06-24
08809416065281SignexA2B.100802025-06-24
08809416065298SignexA2C.100502025-06-24
08809416065410SignexA2A.130502025-06-24
08809595977733SignexA2A.080402025-06-24
08809595977740SignexA2A.080602025-06-24
08809595977757SignexA2A.081202025-06-24
08809595977764SignexA2A.100402025-06-24
08809595977818SignexA2B.080802025-06-24
08809595977832SignexA2C.080602025-06-24
08809416064581SignexA1A.060402025-07-01
08809416064598SignexA1A.061202025-07-01
08809416064604SignexA1C.060702025-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613298657KOMET GUIDE PIN/SCREWGebr. Brasseler GmbH & Co. KGHWC2026-10-14
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00888118132529LEVEL ONE EXTREMITYKLS-Martin L.P.HRS2026-04-23
08057717550009BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550016BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550023BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550030BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550047BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550061BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550290BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550313BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550252BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-08
08057717550276BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-08
B650SCS370450StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370500StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370550StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370600StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370650StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370700StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370750StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370800StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370850StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SCS370900StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830700StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830750StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830800StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830850StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830900StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX830950StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31
B650SFX831000StabilizOrthoStabiliz Orthopaedics, Inc.HWC2024-10-31