Atlas FDA

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

FDA premarket approval P950019/S002 · decided 1998-06-08

Approval details

PMA number
P950019
Supplement
S002
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
Generic name
Intervertebral fusion device with bone graft, lumbar
Applicant
Stryker Spine
Date received
1998-05-08
Decision date
1998-06-08
Days to decision
31 days
Decision code
APPR
Product code
MAX
Advisory committee
Orthopedic
Expedited review
No
Location
Allendale, NJ
Statement
Approval for additional instruments and a change to the surgical technique manual.

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510(k) clearances by this applicant

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