FDA.reportPublic FDA data

POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, Left

Primary DI
07640187463439
Brand
POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, Left
Company
Bonebridge AG
Model
B-261300
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260228000POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG2026-04-24HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640187463439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640187463439076401874634397640187463439

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Regulatory Flags#

DUNS number
480244832
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftB-2611002026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightB-2621002026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftB-2612002026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightB-2622002026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightB-2623002026-05-22
07640187463460POYA Medial TemplateB-4200452026-05-22
07640187462760TAMINA 3.5mm Proximal Humerus Plate, 7 Hole, Long, LeftB-1214002026-01-16
07640187462777TAMINA 3.5mm Proximal Humerus Plate, 7 Hole, Long, RightB-1224002026-01-16
07640187463125Lag Screw Drill Guide 2.5mmB-4100192026-01-16
07640187463132Drill Bit Ø2.5mm x 140mmB-4200442026-01-16
07640187463149Bending Iron SmallB-4100212026-01-16
07640187463156Bending Plier SmallB-4100222026-01-16
07640187463163Cutting PlierB-4100232026-01-16
07640187463101Monoaxial Drill Guide 2.5mmB-4100172026-01-15
07640187463118Insert Monoaxial Drill Guide 2.5mmB-4100182026-01-15
07640187463187BRUSIO 2.5mm Reinforced Straight Plate, 6 HoleB-1710062026-01-15
07640187463194BRUSIO 2.5mm Reinforced Straight Plate, 10 HoleB-1710102026-01-15
07640187463200BRUSIO 2.5mm Reinforced Straight Plate, 14 HoleB-1710142026-01-15
07640187463217BRUSIO 2.5mm Reinforced Straight Plate, 18 HoleB-1710182026-01-15
07640187463224BRUSIO 2.5mm Reinforced Straight Plate, 22 HoleB-1710222026-01-15

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