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A Link Z

FDA UDI

Class II (US FDA UDI)

by Acuity Surgical Devices, Llc

Identity

Trade Name
A Link Z FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
Ø27mm x 19mm x 16° FRA Trial FDA UDI
Model / Reference
10-277196 FDA UDI
Description
Ø27mm x 19mm x 16° FRA Trial FDA UDI

Identifiers

Primary DI / UDI-DI
00810043481908 FDA UDI
510(k) Number
K201671 FDA UDI
FDA Product Code
OVD FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 27 Millimeter FDA UDI
Height — 19 Millimeter FDA UDI
Angle — 16 degree FDA UDI

Category: Spinal implant trial

A Link Z by Acuity Surgical Devices, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K201671 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acuity Surgical Devices, Llc

Sources (1)

  • FDA UDI f839b51b-4348-4d06-880d-28225d8fd2a8 36 fields · synced Jun 8, 2026