Spinenet Acc ® CINS1100

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	NumberB047CINS1100 UDI-DI	Date10 Oct 2016Listed	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Withdrawn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: General internal orthopaedic fixation system implantation kit
Model / Reference: CINS1100

Primary DI / UDI-DI: B047CINS1100
510(k) Number: K110733
FDA Product Code: ODP
GMDN Term: General internal orthopaedic fixation system implantation kit

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

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: 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