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FDA 510(k) Applications Submitted by SCIEN'TX USA INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K990118
01/13/1999
ISOBAR SPINAL SYSTEM
SCIEN'TX USA INC.
K990721
03/05/1999
ISOLOCK SPINAL SYSTEM
SCIEN'TX USA INC.
K991326
04/19/1999
ISOBAR SEMI-RIGID SPINAL SYSTEM
SCIEN'TX USA INC.
K013447
10/17/2001
ISOBAR SPINAL SYSTEM
SCIEN'TX USA INC.
K020245
01/24/2002
MODIFICATION TO ISOBAR SPINAL SYSTEM
SCIEN'TX USA INC.
K013439
10/17/2001
ANTERIOR CERVICAL PLATE SYSTEM
SCIEN'TX USA INC.
K013440
10/17/2001
ISOBAR SPINAL SYSTEM
SCIEN'TX USA INC.
K013444
10/17/2001
ISOBAR SPINAL SYSTEM
SCIEN'TX USA INC.
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