Acp

FDA UDI

Class II (US FDA UDI)

by Sintea Plustek, LLC

Identity

Trade Name: ACP FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Model / Reference: ACP-02T515 FDA UDI

Identifiers

Primary DI / UDI-DI: 08033726409545 FDA UDI
510(k) Number: K041989 FDA UDI
FDA Product Code: KWP FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

Acp by Sintea Plustek, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal fixation plate, non-bioabsorbable.

Zavation — ZAVATION · Class II
Cervalign — Xtant Medical Holdings, Inc. · Class II
CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
TSLP — Synthes · Class II
AESCULAP — AESCULAP, INC. · Class II
PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
ACP — Nuvasive, Inc. · Class II
uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II

Cleared under the same submission

K041989 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sintea Plustek, LLC

Sources (1)

FDA UDI 0456b63c-fa66-4039-b1a6-d9c678cccd09 33 fields · synced May 30, 2026