ACP

GUDID 08033726409569

SINTEA PLUSTEK SRL

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08033726409569
• NIH Device Record Key: fcc07259-6818-407a-901f-e9f529eb3b2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACP
• Version Model Number: ACP-02T517
• Company DUNS: 544150399
• Company Name: SINTEA PLUSTEK SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033726409569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041989

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

[08033726409569]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-10-06

On-Brand Devices [ACP]

• 08057432565746: ACP-04T526
• 08057432565739: ACP-04T525
• 08057432560796: ACP-01T512
• 08033726409835: ACP-04T524
• 08033726409828: ACP-04T523
• 08033726409811: ACP-04T522
• 08033726409804: ACP-04T521
• 08033726409798: ACP-04T520
• 08033726409781: ACP-04T519
• 08033726409774: ACP-04T518
• 08033726409767: ACP-04T517
• 08033726409750: ACP-04T516
• 08033726409743: ACP-04T515
• 08033726409736: ACP-03T524
• 08033726409729: ACP-03T523
• 08033726409712: ACP-03T522
• 08033726409705: ACP-03T521
• 08033726409699: ACP-03T520
• 08033726409682: ACP-03T519
• 08033726409675: ACP-03T518
• 08033726409668: ACP-03T517
• 08033726409651: ACP-03T516
• 08033726409644: ACP-03T515
• 08033726409637: ACP-02T524
• 08033726409620: ACP-02T523
• 08033726409613: ACP-02T522
• 08033726409606: ACP-02T521
• 08033726409590: ACP-02T520
• 08033726409583: ACP-02T519
• 08033726409576: ACP-02T518
• 08033726409569: ACP-02T517
• 08033726409552: ACP-02T516
• 08033726409545: ACP-02T515
• 08033726409538: ACP-02T514
• 08033726409521: ACP-02T513
• 08033726409514: ACP-01T530
• 08033726409507: ACP-01T528
• 08033726409491: ACP-01T526
• 08033726409484: ACP-01T524
• 08033726409477: ACP-01T522
• 08033726409460: ACP-01T520
• 08033726409453: ACP-01T518
• 08033726409446: ACP-01T516
• 08033726409439: ACP-01T514
• 08033726407282: ACP-20T54
• 08033726407275: ACP-18T54
• 08033726407268: ACP-16T54
• 08033726407251: ACP-14T54
• 08033726407244: ACP-20T53
• 08033726407237: ACP-18T53