Syntec Scientific Corp.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under 2 spellings of the applicant name “Syntec Scientific Corp.” (first 1998, latest 2021), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 77 days. Since 2017 the median was 204 days, against 112 days for all cleared 510(k)s in the same product codes. 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 | 1 | 602 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 392 |
| 2018 | 0 | — |
| 2019 | 2 | 204 |
| 2020 | 2 | 28 |
| 2021 | 1 | 360 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Syntec Scientific Corp. took a median 204 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| JDW | Pin, Fixation, Threaded | 2 | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| OAT | Implant, Endosseous, Orthodontic | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (16)
- Dental (3)
Most recent Syntec Scientific Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202790 | Syntec Orthodontic Mini Screw Extended System | OAT | 2021-09-17 | 360 |
| K202935 | Syntec Femoral Nail Extended System | HSB | 2020-10-28 | 29 |
| K200933 | Syntec Non-Sterile Steinmann Pins System | JDW | 2020-05-05 | 28 |
| K191617 | Syntec Tibial Nail System | HSB | 2019-09-03 | 77 |
| K181296 | Syntec Femoral Nail System | HSB | 2019-04-11 | 330 |
| K161327 | SYNTEC HUMERAL NAIL SYSTEM | HSB | 2017-06-08 | 392 |
| K111189 | SYNTEC DENTAL IMPLANT | DZE | 2012-12-20 | 602 |
| K101971 | SYNTEC OS SPINAL FIXATION SYSTEM | NKB | 2011-03-25 | 255 |
| K092889 | SYNTEC OSTEO-PLATE AND SCREW FIXATION | HRS | 2010-06-25 | 277 |
| K090476 | SYNTEC ORTHODONTIC MINI SCREW | OAT | 2009-06-18 | 114 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Syntec Scientific Corp..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Syntec Scientific Corp. (13)
- Syntec Scientific Corporation (6)
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.
- Syntec, Inc. (3 510(k)s)
- Syntec Scientific Corporation - Taipei Office (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Syntec Scientific Corp.?
FDA lists 19 510(k) clearances under 2 spellings of the applicant name “Syntec Scientific Corp.” (first 1998, latest 2021), across 9 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 Syntec Scientific Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syntec Scientific Corp. is 77 days. Since 2017: 204 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Syntec Scientific Corp.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 6); HRS (Plate, Fixation, Bone, 3); JDW (Pin, Fixation, Threaded, 2).
Next steps
- See all 19 Syntec Scientific Corp. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Syntec Scientific Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.