Bone Fixation Cerclage, Sublaminar
FDA product code OWI · 31 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3010
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2011-08-11 – 2026-05-27
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
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Spinal Elements Cerclage System
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2018-08-29
ResCUBE™ Ligament Fixation System
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2018-04-10
NAJA™ Ligament Correction System
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2018-04-03
LigaPASS
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2017-12-07
NuVasive® VersaTie™ System
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2017-10-26
SILC® Fixation System
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2017-08-30
LigaPASS
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2017-08-08
JAZZ Passer Band
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2017-06-09
JAZZ System, including JAZZ Band
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2017-05-16
TRANSLACE™ Spinal Tethering System
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2017-04-05
NILE Proximal Fixation Spinal System
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2016-09-02
LigaPASS
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OWI
2016-08-11
Response BandLoc Spinal Fixation
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OWI
2016-07-15
NuVasive® VersaTie System
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OWI
2016-03-31
JAZZ LOCK
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OWI
2016-03-18
NILE Alternative Fixation Spinal System
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OWI
2013-12-06
LIGAPASS
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OWI
2013-09-25
JAZZ SYSTEM
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OWI
2011-08-11
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
View details →No matching devices.
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