Atlas FDA

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set

FDA 510(k) clearance K171938 · decided 2017-10-23

Clearance details

K-number
K171938
Device name
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2017-06-28
Decision date
2017-10-23
Days to decision
117 days
Clearance type
Traditional
Product code
PML
Device class
2
Regulation number
888.3027
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Dynamo™ Spinal Cement; Salvo® Spine System (K260286)Spine Wave, Inc.2026-06-15
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Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (K241034)Medacta International S.A.2024-06-12
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (K231809)Ulrich Medical USA2023-10-20
PERLA® TL System; TEKTONA® HV US Bone Cement (K230774)Spineart2023-06-23
VADER® Pedicle System, G21 Cement (K222789)Icotec AG2023-01-09
Invictus® Bone Cement, Invictus Spinal Fixation System (K221926)Alphatec Spine, Inc.2022-12-20
BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (K222256)Neo Medical SA2022-08-26
BonOs Inject Bone Cement; NEO Pedicle Screw System (K212489)Neo Medical SA2021-10-28
G21 Cement, VADER® Pedicle System (K200596)Icotec AG2020-10-13
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement (K201362)Medtronic2020-08-19
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System (K192818)Stryker Corporation2020-03-31

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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HeartWare HVAD System (P100047/S226)Medtronic2025-05-05
HeartWare® HVAD System (P100047/S225)Medtronic2025-04-24
HeartWare HVAD System (P100047/S224)Medtronic2025-04-02
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222)Medtronic2025-03-13