GPS Cervical Spacers
FDA 510(k) K210890 · G Surgical, LLC
510(k) numberK210890
Submission
- Device name
- GPS Cervical Spacers
- Applicant
- G Surgical, LLC
Austin, TX, US - Received
- March 25, 2021
- Decision date
- April 23, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K240737 | G Surgical Marksman MIS SystemNKB · Special | 04/05/2024SE |
| K230063 | G Surgical Marksman Spinal Deformity SystemNKB · Special | 02/09/2023SE |
| K193219 | G Surgical Marksman SystemNKB · Special | 12/17/2019SE |
| K171834 | G Surgical OCT Spinal SystemNKG · Traditional | 12/19/2017SE |
| K161516 | G Surgical Marksman MIS SystemNKB · Traditional | 08/25/2016SE |
| K142456 | GPS SpacersODP · Traditional | 04/10/2015SE |
| K103070 | GPS TM, G Surgical Anterior Cervical Plate System +KWQ · Traditional | 01/12/2011SE |
| K081041 | GPS, G Surgical Pedicle SystemMNH · Traditional | 06/27/2008SE |
Questions and answers
When was GPS Cervical Spacers cleared by the FDA?
GPS Cervical Spacers (K210890) received a 510(k) decision of Substantially Equivalent on April 23, 2021, 29 days after the submission was received.
What is the product code of K210890?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.