Inion , Ltd.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Inion , Ltd.” (first 2001, latest 2008), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 54 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 9 | 9 |
| JEY | Plate, Bone | 6 | 6 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| OJB | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate | 2 | 2 |
| NPK | Barrier, Synthetic, Intraoral | 1 | 1 |
Review panels
- Orthopedic (16)
- Dental (7)
Most recent Inion , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071810 | INION SPINAL GRAFT CONTAINMENT SYSTEM | OJB | 2008-07-11 | 375 |
| K063410 | INION CPS/OTPS FREEDOMPLATE | HRS | 2007-01-23 | 71 |
| K062617 | MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM | HWC | 2006-10-04 | 29 |
| K060393 | INION HEXALON BIODEGRADABLE ACL/PCL SCREW | HWC | 2006-03-13 | 26 |
| K051821 | INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM | OJB | 2005-11-25 | 143 |
| K052624 | INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE | HRS | 2005-11-16 | 54 |
| K052444 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM | JEY | 2005-09-20 | 14 |
| K051341 | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 | JEY | 2005-05-27 | 4 |
| K050275 | MODIFICATION TO: INION OTPS BIODEGRADABLE PIN | HTY | 2005-03-07 | 28 |
| K043142 | INION OTPS BIODEGRADABLE MINI PLATING SYSTEM | HWC | 2005-02-18 | 95 |
13 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-03-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Inion OY (14 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inion , Ltd.?
FDA lists 23 510(k) clearances under the applicant name “Inion , Ltd.” (first 2001, latest 2008), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Inion , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inion , Ltd. is 54 days.
Which FDA product codes appear under Inion , Ltd.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 9); JEY (Plate, Bone, 6); HRS (Plate, Fixation, Bone, 3).
Next steps
- See all 23 Inion , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Inion , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.