Spinenet Acc® CL121405

by SpineNet LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB047CL1214050 UDI-DI	Date5 Oct 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-2103-2013 FDA Class II initiated 5 Feb 2013
The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Spinenet Acc®
Generic Name: Polymeric spinal interbody fusion cage
Model / Reference: CL121405

Primary DI / UDI-DI: B047CL1214050
510(k) Number: K110733
FDA Product Code: ODP
GMDN Term: Polymeric spinal interbody fusion cage

Device Class: Class II
Regulation Number: 888.3080
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Height — 5 Millimeter
Width — 14 Millimeter
Length — 12 Millimeter

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No