FDA.reportPublic FDA data

Signex

Primary DI
08800071023265
Brand
Signex
Company
OSTEONIC CO.,Ltd.
Model
S3B.50550
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
08800071023265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800071023265088000710232658800071023265

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
00688346003918Fine TTOLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
B562PKSMC0635NSLTI0WishBone Plate & Screw SystemWishbone Medical, Inc.HRS2021-09-07
B562PKSMC0635NSRTI0WishBone Plate & Screw SystemWishbone Medical, Inc.HRS2021-09-07
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B562MPKCSST4040T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4040TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4042T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4042TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4044T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4044TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4050T0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562MPKCSST4050TUS0Malleolar Procedure KitWishbone Medical, Inc.HWC2021-02-17
B562PKTCX27LG0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX27LGUS0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX27SM0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX27SMUS0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX35LG0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX35LGUS0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02
B562PKTCX35SM0WishBone Plate & Screw SystemWishbone Medical, Inc.HWC2020-12-02