Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)
FDA 510(k) K123672 · Inion OY
510(k) numberK123672
Submission
- Device name
- Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)
- Applicant
- Inion OY
Tampere, FI - Received
- November 29, 2012
- Decision date
- February 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 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 |
| 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 |
| K070998 | Inion BiorestoreMQV · Traditional | 10/11/2007SE |
Questions and answers
When was Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) cleared by the FDA?
Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew) (K123672) received a 510(k) decision of Substantially Equivalent on February 27, 2013, 90 days after the submission was received.
What is the product code of K123672?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.