Sintea Biotech, Inc.: FDA clearances and approvals
Sintea Biotech, Inc. has 10 FDA 510(k) clearances (first 2002, latest 2009), across 7 product codes in 1 review panel. Median 510(k) review time: 64 days.
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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Sintea Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082679 | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X | JEC | 2009-04-07 | 204 |
| K081631 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS | MNH | 2008-07-18 | 37 |
| K072198 | X-VOID, SPIDER | HRX | 2008-06-06 | 304 |
| K070181 | SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX | MQP | 2007-04-18 | 89 |
| K060513 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X | KWP | 2006-03-10 | 11 |
| K043355 | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X | KWP | 2004-12-17 | 11 |
| K041989 | SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X | KWQ | 2004-09-16 | 55 |
| K031154 | SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X | JDW | 2003-06-24 | 74 |
| K020085 | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X | MNH | 2002-12-10 | 334 |
| K022065 | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X | JEC | 2002-08-06 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Sintea Biotech, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sintea Biotech, Inc. have?
Sintea Biotech, Inc. has 10 FDA 510(k) clearances (first 2002, latest 2009), across 7 product codes in 1 review panel.
How long does FDA take to clear Sintea Biotech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sintea Biotech, Inc.'s cleared 510(k)s is 64 days.
What devices does Sintea Biotech, Inc. make?
Its most frequent FDA product codes are JEC (Component, Traction, Invasive, 2); KWP (Appliance, Fixation, Spinal Interlaminal, 2); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 2).
Has Sintea Biotech, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sintea Biotech, Inc. Related entities may recall under other names.
Next steps
- See all 10 Sintea Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JEC, Sintea Biotech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.