Inion S-1 Biodegradable Anterior Cervical Fusion System
FDA 510(k) K051821 · Inion , Ltd.
510(k) numberK051821
Submission
- Device name
- Inion S-1 Biodegradable Anterior Cervical Fusion System
- Applicant
- Inion , Ltd.
Tampere, FI - Received
- July 5, 2005
- Decision date
- November 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OJB – Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.
Other 510(k)s with product code OJB
More from Inion , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…JEY · Traditional | 11/07/2025SE |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable…HBW · Traditional | 07/11/2025SE |
| K203105 | Inion CompressOn ScrewHWC · Traditional | 01/13/2021SE |
| K191764 | Inion BioRestoreMQV · Special | 07/31/2019SE |
| K151360 | Inion Spinal Graft Containment SystemOJB · Traditional | 10/06/2015SESU |
| K133932 | Inion FreedompinHTY · Traditional | 04/11/2014SE |
| K123672 | Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)HWC · Traditional | 02/27/2013SE |
| K122890 | Inion CPS Orbital PlatesJEY · Traditional | 01/29/2013SE |
| K090177 | Inion Biorestore Biodegradable Bone Graft SubstituteMQV · Special | 02/20/2009SE |
| K071810 | Inion Spinal Graft Containment SystemOJB · Traditional | 07/11/2008SESU |
Questions and answers
When was Inion S-1 Biodegradable Anterior Cervical Fusion System cleared by the FDA?
Inion S-1 Biodegradable Anterior Cervical Fusion System (K051821) received a 510(k) decision of Substantially Equivalent on November 25, 2005, 143 days after the submission was received.
What is the product code of K051821?
The FDA product code is OJB – Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3060.