CORBEL Spacers
FDA 510(k) K201087 · Globus Medical, Inc.
510(k) numberK201087
Submission
- Device name
- CORBEL Spacers
- Applicant
- Globus Medical, Inc.
Audubon, PA, US - Received
- April 23, 2020
- Decision date
- July 31, 2020
- 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.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K254043 | TRIVANCE Hip StemLPH · Traditional | 08/04/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | 07/31/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | 05/07/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | 04/29/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | 04/24/2026SE |
| K252166 | RIB LINK Fixation SystemHRS · Traditional | 02/26/2026SE |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer)OVE · Special | 12/22/2025SE |
| K250599 | ExcelsiusGPS InstrumentsOLO · Traditional | 11/05/2025SE |
| K251161 | ANTHEM® Fracture SystemHRS · Traditional | 08/18/2025SE |
| K241525 | ExcelsiusXRSBF · Traditional | 07/08/2025SE |
Questions and answers
When was CORBEL Spacers cleared by the FDA?
CORBEL Spacers (K201087) received a 510(k) decision of Substantially Equivalent on July 31, 2020, 99 days after the submission was received.
What is the product code of K201087?
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.