Anyplus PEEK Cages
FDA 510(k) K100516 · GS Medical Co., Ltd.
510(k) numberK100516
Submission
- Device name
- Anyplus PEEK Cages
- Applicant
- GS Medical Co., Ltd.
Douglassville, PA, US - Received
- February 23, 2010
- Decision date
- December 3, 2010
- 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 |
More from Alphatec Spine
| 510(k) | Device | Decision |
|---|---|---|
| K243073 | AnyPlus Navigated Instruments SystemOLO · Traditional | 12/06/2024SE |
| K241738 | PYXIS 3D Titanium Cervical Cage systemODP · Traditional | 08/20/2024SE |
| K240350 | AnyPlus II Spinal Fixation SystemNKB · Traditional | 04/03/2024SE |
| K231808 | QUASAR Standalone ACIF SystemOVE · Special | 07/20/2023SE |
| K223868 | PYXIS 3D Titanium Cage SystemMAX · Traditional | 04/26/2023SE |
| K222041 | CYGNUS-C Standalone ACIF SystemOVE · Traditional | 02/09/2023SE |
| K221687 | Pegasus-X Expandable PLIF SystemMAX · Traditional | 07/27/2022SE |
| K211797 | TRACKER Plus Kyphoplasty SystemNDN · Traditional | 10/28/2021SE |
| K200592 | GS Medical AnyPlus PEEK Cage SystemODP · Traditional | 08/10/2020SE |
| K192335 | TRACKER Kyphoplasty SystemNDN · Traditional | 12/04/2019SE |
Questions and answers
When was Anyplus PEEK Cages cleared by the FDA?
Anyplus PEEK Cages (K100516) received a 510(k) decision of Substantially Equivalent on December 3, 2010, 283 days after the submission was received.
What is the product code of K100516?
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.