Mecta-C TiPEEK
FDA 510(k) K142744 · Medacta International
510(k) numberK142744
Submission
- Device name
- Mecta-C TiPEEK
- Applicant
- Medacta International
Castel San Pietro, CH - Received
- September 24, 2014
- Decision date
- May 7, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
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| K143453 | Mpact Double Mobility SystemLPH · Traditional | 03/02/2015SE |
| K142069 | GMK ExtensionJWH · Traditional | 12/02/2014SE |
| K141988 | M.U.S.T Pedicle Screw SystemNKB · Special | 08/19/2014SE |
| K141044 | M.U.S.T. ExtensionNKB · Traditional | 08/18/2014SE |
| K140826 | GMK Sphere ExtensionJWH · Traditional | 07/15/2014SE |
Questions and answers
When was Mecta-C TiPEEK cleared by the FDA?
Mecta-C TiPEEK (K142744) received a 510(k) decision of Substantially Equivalent on May 7, 2015, 225 days after the submission was received.
What is the product code of K142744?
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.