Acumed

FDA UDI

Class I (US FDA UDI)

by Acumed Llc

Identity

Trade Name: ACUMED FDA UDI
Generic Name: Bone tack inserter, basic FDA UDI
Device Name: Plate Tack FDA UDI
Model / Reference: PL-PTACK-S FDA UDI
Description: Plate Tack FDA UDI

Identifiers

Primary DI / UDI-DI: 10806378116704 FDA UDI
510(k) Number: K233311 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone tack inserter, basic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Category: Bone tack inserter, basic

Acumed by Acumed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone tack inserter, basic.

Cyclops Anterior Cervical Plate System — Degen Medical · Class I
Aluminium Tack Placement Instrument — MC BIO SRL · Class I
Back Applicator — MC BIO SRL · Class I
Offset Tip — MC BIO SRL · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC. · Class I
Standard tip — MC BIO SRL · Class I
Flower Orthopedics — FLOWER ORTHOPEDICS CORPORATION · Class I

Cleared under the same submission

K233311 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 I	Pending data

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Manufacturer

Manufacturer: Acumed Llc

Sources (1)

FDA UDI 5bb8e599-1bf8-493d-88d4-551ce1d0c87d 35 fields · synced Jun 8, 2026