Atlas FDA

CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)

FDA 510(k) clearance K232141 · decided 2023-08-16

Clearance details

K-number
K232141
Device name
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
Applicant
Medtronic Sofamor Danek USA, Inc.
Decision
Substantially Equivalent
Date received
2023-07-18
Decision date
2023-08-16
Days to decision
29 days
Clearance type
Special
Product code
NKB
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Tiger 2 System (K253943)Zavation Medical Products, LLC2026-07-24
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Infuse TM Bone Graft/Medtronic lnterbody Fusion Device (P000058/S099)Medtronic Sofamor Danek USA, Inc.2026-07-28
Infuse™ Bone Graft (P000054/S078)Medtronic Sofamor Danek USA, Inc.2026-07-28
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S098)Medtronic Sofamor Danek USA, Inc.2026-03-19
INFUSE® Bone Graft (P000054/S077)Medtronic Sofamor Danek USA, Inc.2026-03-19
INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S097)Medtronic Sofamor Danek USA, Inc.2026-02-24
INFUSE Bone Graft (P000054/S076)Medtronic Sofamor Danek USA, Inc.2026-02-24
Infuse Bone Graft (P000058/S096)Medtronic Sofamor Danek USA, Inc.2026-02-13
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S094)Medtronic Sofamor Danek USA, Inc.2025-03-19