Twin City Surgical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Twin City Surgical, Inc.” (first 1981, latest 1987), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 22 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 |
|---|---|---|---|
| GAD | Retractor | 1 | 1 |
| HXC | Wrench | 1 | 1 |
| IKK | System, Isokinetic Testing And Evaluation | 1 | 1 |
| KQW | Goniometer, Nonpowered | 1 | 1 |
| KTZ | Caliper | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Review panels
- Orthopedic (3)
- Neurology (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Twin City Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870767 | THE (CROM) TESTER | KQW | 1987-03-17 | 19 |
| K861632 | SIMS CHAIR | IKK | 1986-05-27 | 28 |
| K830585 | ANVIL RETRACTOR | GAD | 1983-05-27 | 93 |
| K820660 | A HOOK DRIVER | KWP | 1982-03-19 | 9 |
| K820659 | A CALIPER | KTZ | 1982-03-19 | 9 |
| K813067 | SPINAL WRENCH | HXC | 1981-11-24 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Twin City Surgical, Inc..
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.
- Twin Star Medical, Inc. (4 510(k)s)
- Twin Falls Orthopedic Associates, P.A. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Twin City Surgical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Twin City Surgical, Inc.” (first 1981, latest 1987), across 6 product codes in 4 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 Twin City Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Twin City Surgical, Inc. is 22 days.
Which FDA product codes appear under Twin City Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GAD (Retractor, 1); HXC (Wrench, 1); IKK (System, Isokinetic Testing And Evaluation, 1).
Next steps
- See all 6 Twin City Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAD, Twin City Surgical, Inc.'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.