510(k) K153042 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
TRYPTIK2C-plate Anterior Cervical Plate System
| Applicant | Spineart, Geneva, CH |
| Decision | Substantially Equivalent, Mar 28, 2016 |
| Received | Oct 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153042
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | None listed |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | None listed |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | None listed |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizati Terminated |
KWQ | None listed |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | None listed |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | None listed |
| Nov 27, 2017 | SPINEART SA TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2
TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilizatio Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.