Device Listing 1003652895

Listing Summary#

Listing key: 1003652895
Premarket submission: K260216
Device: CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System
Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: NKB
Decision date: 2026-04-21

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
5761	1030489	1000477302	MEDTRONIC SOFAMOR DANEK USA, INC.	1	Y	2026-01-01	1800 PYRAMID PLACE Memphis TN US 38132
5811	2647346	2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	1	Y	2026-01-01	ROAD 909, KM. 0.4. BARRIO MARIANA HUMACAO PR US 00792
135265	3009380063	3009380063	Medtronic Distribution Center	1	N	2026-01-01	5300 Airways Blvd Memphis TN US 38116
278187	3011577940	3011577940	Titan Spine, a Division of Medtronic	1	N	2026-01-01	8347 N Steven Rd Milwaukee WI US 53223
312405	3018094310	3018094310	Medtronic Engineering and Innovation Center (MEIC)	1	N	2026-01-01	BSR Tech Park Survey No.135, 138, 141 & 142 Nanakramguda Main Hyderabad Telangana IN 500032