FDA.reportPublic FDA data

LORRAINE 3.5mm Posterolateral Distal Humerus Plate, 8 Hole, Right

Primary DI
07640187462104
Brand
LORRAINE 3.5mm Posterolateral Distal Humerus Plate, 8 Hole, Right
Company
Bonebridge AG
Model
B-162100
Published
2023-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
K231292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231292000TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus SystemBonebridge AG2023-07-19HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640187462104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640187462104076401874621047640187462104

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480244832
Device count
1
Lot or batch
true
Expiration date on label
true

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
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftB-2613002026-05-22
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

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