Atlas FDA

Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus

FDA 510(k) clearance K192502 · decided 2020-01-22

Clearance details

K-number
K192502
Device name
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus
Applicant
Medtronic Sofamor Danek USA, Inc.
Decision
Substantially Equivalent
Date received
2019-09-12
Decision date
2020-01-22
Days to decision
132 days
Clearance type
Traditional
Product code
MAX
Device class
2
Regulation number
888.3080
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
TruLift Expandable System (K261430)Life Spine, Inc.2026-07-28
Catalyft PL Expandable Interbody System (K253011)Medtronic Sofamor Danek USA, Inc.2026-07-17
Symmetrix™ L Spinal System (K261020)Medtronic Sofamor Danek USA, Inc.2026-07-14
Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (K253420)SeaSpine Orthopedics Corporation2026-07-01
Fule Interbody Fusion Cage System (K253151)Beijing Fule Science & Technology Development Co., Ltd.2026-06-15
Exceed® Biplanar Expandable Interbody System (K261159)Spine Wave, Inc.2026-05-29
BMD Titanium Spinal Fusion System (K253894)Global Biomedica s.r.o.2026-05-28
Ventana® P/T Lumbar Interbody System (K260506)Spinal Elements, Inc.2026-05-15
VersaLift Expandable System (K260837)Life Spine, Inc.2026-05-12
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (K260385)Carlsmed, Inc.2026-05-09
BEE PLIF Cage (K261067)NGMedical GmbH2026-04-30
SWINGO-3D Lumbar Cage System (K254017)Implanet2026-02-26

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