P.A.C.E.

GUDID 04251944101797

Cortical Screw ø2,8mm, L12mm

MAXXOS - Medical GmbH

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 04251944101797
• NIH Device Record Key: 85710cc8-c663-4ad2-bf33-33ca265fe0eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.A.C.E.
• Version Model Number: M112128-012
• Company DUNS: 313262497
• Company Name: MAXXOS - Medical GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	04251944101797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251892

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

[04251944101797]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-22
• Device Publish Date: 2025-12-14

On-Brand Devices [P.A.C.E.]

• 04251944144640: P.A.C.E. MTP Fusion Plate, comp. 0°, Long, Right
• 04251944144633: P.A.C.E. MTP Fusion Plate, comp. 0°, Long, Left
• 04251944144626: P.A.C.E. MTP Fusion Plate, comp. 5°, Long, Right
• 04251944144619: P.A.C.E. MTP Fusion Plate, comp. 5°, Long, Left
• 04251944144602: P.A.C.E. MTP Fusion Plate, comp. 10°, Long, Right
• 04251944144596: P.A.C.E. MTP Fusion Plate, comp. 10°, Long, Left
• 04251944144589: P.A.C.E. MTP Fusion Plate, comp. 0°, Medium, Right
• 04251944144572: P.A.C.E. MTP Fusion Plate, comp. 0°, Medium, Left
• 04251944144565: P.A.C.E. MTP Fusion Plate, comp. 5°, Medium, Right
• 04251944144558: P.A.C.E. MTP Fusion Plate, comp. 5°, Medium, Left
• 04251944144541: P.A.C.E. MTP Fusion Plate, comp. 10°, Medium, Right
• 04251944144534: P.A.C.E. MTP Fusion Plate, comp. 10°, Medium, Left
• 04251944144527: P.A.C.E. MTP Fusion Plate, comp. 0°, Short, Right
• 04251944144510: P.A.C.E. MTP Fusion Plate, comp. 0°, Short, Left
• 04251944144503: P.A.C.E. MTP Fusion Plate, comp. 5°, Short, Right
• 04251944144497: P.A.C.E. MTP Fusion Plate, comp. 5°, Short, Left
• 04251944144480: P.A.C.E. MTP Fusion Plate, comp. 10°, Short, Left
• 04251944144473: P.A.C.E. MTP Fusion Plate, comp. 10°, Short, Left
• 04251944141380: P.A.C.E. MTP Fusion Plate 0°, narrow, Right, 2,5/2,8mm System
• 04251944141373: P.A.C.E. MTP Fusion Plate 5°, narrow, Right2,5/2,8mm System
• 04251944141366: P.A.C.E. MTP Fusion Plate, narrow, Right, 2,5/2,8mm System
• 04251944141359: P.A.C.E. MTP Fusion Plate 0°, narrow, Left, 2,5/2,8mm System
• 04251944141342: P.A.C.E. MTP Fusion Plate 5°, narrow, Left, 2,5/2,8mm System
• 04251944141335: P.A.C.E. MTP Fusion Plate, narrow, Left2,5/2,8mm System
• 04251944125908: P.A.C.E. MTP Fusion Plate 0°, Right, 2,5/2,8mm System
• 04251944125892: P.A.C.E. MTP Fusion Plate 5°, Right2,5/2,8mm System
• 04251944125885: P.A.C.E. MTP Fusion Plate 0°, Left2,5/2,8mm System
• 04251944125878: P.A.C.E. MTP Fusion Plate 5°, Left2,5/2,8mm System
• 04251944111994: MVA CorticaLLocking Screw ø2,8mm,L14mm
• 04251944103692: P.A.C.E. MTP Fusion Revision Plate, 2,5/2,8mm System, Right
• 04251944103685: P.A.C.E. MTP Fusion Revision Plate,2,5/2,8mm System, Left
• 04251944103678: P.A.C.E. MTP Fusion Plate 5°, Right, 2,5/2,8mm System
• 04251944102152: Cortical Screw ø3,0mm, L30mm
• 04251944102145: Cortical Screw ø3,0mm, L28mm
• 04251944102138: Cortical Screw ø3,0mm, L26mm
• 04251944102121: Cortical Screw ø3,0mm, L24mm
• 04251944102114: Cortical Screw ø3,0mm, L22mm
• 04251944102107: Cortical Screw ø3,0mm, L20mm
• 04251944102091: Cortical Screw ø3,0mm, L18mm
• 04251944102084: Cortical Screw ø3,0mm, L16mm
• 04251944102077: Cortical Screw ø3,0mm, L14mm
• 04251944102060: Cortical Screw ø3,0mm, L12mm
• 04251944102053: Cortical Screw ø3,0mm, L10mm
• 04251944101995: MVA Cortical Locking Screw ø3,0mm, L30mm
• 04251944101988: MVA Cortical Locking Screw ø3,0mm, L28mm
• 04251944101971: MVA Cortical Locking Screw ø3,0mm, L26mm
• 04251944101964: MVA Cortical Locking Screw ø3,0mm, L24mm
• 04251944101957: MVA Cortical Locking Screw ø3,0mm, L22mm
• 04251944101940: MVA Cortical Locking Screw ø3,0mm, L20mm
• 04251944101933: MVA Cortical Locking Screw ø3,0mm, L18mm