TiGer Shark System
FDA 510(k) K172816 · Choicespine, LP
510(k) numberK172816
Submission
- Device name
- TiGer Shark System
- Applicant
- Choicespine, LP
Knoxville, TN, US - Received
- September 18, 2017
- Decision date
- January 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| K182721 | Choice Spine Navigation SystemOLO · Traditional | 01/08/2019SE |
| K183214 | Raven Lumbar Plate SystemKWQ · Traditional | 01/03/2019SE |
| K180519 | HARRIER-SA Lumbar Interbody SystemOVD · Traditional | 05/16/2018SE |
| K173215 | Choice Spine Laminoplasty Fixation SystemNQW · Traditional | 01/19/2018SE |
| K171489 | Acapella Cervical Spacer SystemOVE · Traditional | 10/23/2017SE |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Traditional | 09/15/2017SE |
| K171456 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw SystemsNKB · Traditional | 08/03/2017SE |
Questions and answers
When was TiGer Shark System cleared by the FDA?
TiGer Shark System (K172816) received a 510(k) decision of Substantially Equivalent on January 26, 2018, 130 days after the submission was received.
What is the product code of K172816?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.