HARRIER-SA Lumbar Interbody System
FDA 510(k) K180519 · Choicespine, LP
510(k) numberK180519
Submission
- Device name
- HARRIER-SA Lumbar Interbody System
- Applicant
- Choicespine, LP
Knoxville, TN, US - Received
- February 27, 2018
- Decision date
- May 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
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| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
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Questions and answers
When was HARRIER-SA Lumbar Interbody System cleared by the FDA?
HARRIER-SA Lumbar Interbody System (K180519) received a 510(k) decision of Substantially Equivalent on May 16, 2018, 78 days after the submission was received.
What is the product code of K180519?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.