APTUS A-4954.25S

GUDID 07630037830986

2.8/3.5 TriLock Distal Tibia Plate Medial, 25 Hole, Left

Medartis AG

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 07630037830986
• NIH Device Record Key: 71fc0fcb-dbd3-4bc0-88cd-a23cf094b2fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APTUS
• Version Model Number: A-4954.25S
• Catalog Number: A-4954.25S
• Company DUNS: 480054895
• Company Name: Medartis AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630037830986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193633

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-16
• Device Publish Date: 2020-05-22

On-Brand Devices [APTUS]

• 07630037811671: 2.0 TriLock CMC-I Fusion Pl 3x2Hole,t1.3
• 07630037808534: 3.5 TriLock Prox. Hum. Plate XL, 14H, R
• 07630037808527: 3.5 TriLock Prox. Hum. Plate XL, 14H, L
• 07630037808510: 3.5 TriLock Prox. Hum. Plate XL, 10H, R
• 07630037808503: 3.5 TriLock Prox. Hum. Plate XL, 10H, L
• 07630037804888: 2.5 TriLock Dist.Rad. Rim Pl Volar Right
• 07630037804871: 2.5 TriLock Dist.Rad. Rim Pl Volar Left
• 07630037804864: 2.5 TriLock Lunate Facet Pl Volar Right
• 07630037804857: 2.5 TriLock Lunate Facet Pl Volar Left
• 07630037804451: 2.2 K-Wire, Trocar, 250mm, 1/Pkg
• 07630037804444: 1.6 K-Wire, Trocar, 200mm, 1/Pkg
• 07630037804284: 7.0 CCS Screw 30mm, HD25, 1/Pkg
• 07630037804277: 7.0 CCS Screw 35mm, HD25, 1/Pkg
• 07630037804260: 7.0 CCS Screw 50mm, HD25, 1/Pkg
• 07630037804253: 7.0 CCS Screw 55mm, HD25, 1/Pkg
• 07630037804246: 7.0 CCS Screw 45mm, HD25, 1/Pkg
• 07630037804239: 7.0 CCS Screw 35mm, HD25, 1/Pkg
• 07630037804222: 7.0 CCS Screw 35mm, HD25, 1/Pkg
• 07630037804215: 5.0 CCS Screw 22mm, HD15, 1/Pkg
• 07630037804208: 5.0 CCS Screw 24mm, HD15, 1/Pkg
• 07630037804192: 5.0 CCS Screw 20mm, HD15, 1/Pkg
• 07630037804185: 5.0 CCS Screw 28mm, HD15, 1/Pkg
• 07630037804178: 5.0 CCS Screw 38mm, HD15, 1/Pkg
• 07630037804161: 5.0 CCS Screw 34mm, HD15, 1/Pkg
• 07630037804154: 5.0 CCS Screw 30mm, HD15, 1/Pkg
• 07630037804147: 5.0 CCS Screw 36mm, HD15, 1/Pkg
• 07630037804130: 5.0 CCS Screw 32mm, HD15, 1/Pkg
• 07630037804123: 5.0 CCS Screw 26mm, HD15, 1/Pkg
• 07630037804116: 5.0 CCS Screw 22mm, HD15, 1/Pkg
• 07630037804109: 5.0 CCS Screw 20mm, HD15, 1/Pkg
• 07630037804093: 5.0 CCS Screw 28mm, HD15, 1/Pkg
• 07630037803508: 5.0 CCS Screw 24mm, HD15, 1/Pkg
• 07630008491512: 2.5/2.8 Concave Washer, 1/Pkg
• 07630008491482: 2.5/2.8 Concave Washer, 5/Pkg
• 07630008491390: 2.0 TriLock Coronoid Plate Right
• 07630008491369: 2.0 TriLock Coronoid Plate Left
• 07630008491307: 4.0 Transfixation Screw 45mm, HD7, 1/Pkg
• 07630008491277: 4.0 Transfixation Screw 40mm, HD7, 1/Pkg
• 07630008491246: 4.0 Transfixation Screw 38mm, HD7, 1/Pkg
• 07630008491215: 4.0 Transfixation Screw 36mm, HD7, 1/Pkg
• 07630008491185: 4.0 Transfixation Screw 34mm, HD7, 1/Pkg
• 07630008491154: 4.0 Transfixation Screw 32mm, HD7, 1/Pkg
• 07630008491123: 4.0 Transfixation Screw 30mm, HD7, 1/Pkg
• 07630008491093: 4.0 Transfixation Screw 28mm, HD7, 1/Pkg
• 07630008491062: 5.0 CCS Screw 26mm, HD15, 1/Pkg
• 07630008491031: 7.0 CCS Screw 30mm, HD25, 1/Pkg
• 07630008491000: 7.0 CCS Screw 40mm, HD25, 1/Pkg
• 07630008490973: 2.2 K-Wire, Trocar, 250mm, 10/Pkg
• 07630008490966: 1.6 K-Wire, Trocar, 200mm, 10/Pkg
• 07630008490669: 1.6 K-Wire, Threaded, 200/10mm, 10/Pkg