Atlas FDA

RAY TFC DEVICE AND RAY TFC UNITE DEVICE

FDA premarket approval P950019/S009 · decided 2000-03-02

Approval details

PMA number
P950019
Supplement
S009
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
RAY TFC DEVICE AND RAY TFC UNITE DEVICE
Generic name
Intervertebral fusion device with bone graft, lumbar
Applicant
Stryker Spine
Date received
1999-05-03
Decision date
2000-03-02
Days to decision
304 days
Decision code
APPR
Product code
MAX
Advisory committee
Orthopedic
Expedited review
No
Location
Allendale, NJ
Statement
Modified indications for use for the Ray TFC and Unite Threaded Fusion Cage with instrumentation. These devices are indicated for use with autogenous bone grafts in patients with degenerative disc disease (DDD) at one or two levels for L2 to S1.

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510(k) clearances by this applicant

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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
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