Atlas FDA

RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION

FDA premarket approval P950019/S011 · decided 2000-03-30

Approval details

PMA number
P950019
Supplement
S011
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION
Generic name
Intervertebral fusion device with bone graft, lumbar
Applicant
Stryker Spine
Date received
2000-03-21
Decision date
2000-03-30
Days to decision
9 days
Decision code
OK30
Product code
MAX
Advisory committee
Orthopedic
Expedited review
No
Location
Allendale, NJ
Statement
REMOVAL OF THE POST STERILIZATION INSPECTION FOR THE RAY THREADED FUSION CAGE WITH INSTRUMENTATION.

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510(k) clearances by this applicant

RecordFirmDate
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Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute (K261008)Stryker Spine2026-04-24
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Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips (K242280)Stryker Spine2024-08-29
XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (K222684)Stryker Spine2023-06-08
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