Innovative Surgical Designs, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Innovative Surgical Designs, Inc.” (first 2013, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 128 days. Since 2017 the median was 61 days, against 68 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 |
|---|---|---|
| 2013 | 1 | 195 |
| 2014 | 1 | 156 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 92 |
| 2018 | 1 | 56 |
| 2019 | 0 | — |
| 2020 | 1 | 22 |
| 2021 | 1 | 61 |
| 2022 | 2 | 204 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Innovative Surgical Designs, Inc. took a median 61 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 68 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 7 | 7 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Innovative Surgical Designs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220297 | True Tulip, True M.I.S. | NKB | 2022-09-16 | 226 |
| K212627 | True Tulip, True M.I.S. | NKB | 2022-02-18 | 183 |
| K210816 | True Tulip, True M.I.S. | NKB | 2021-05-18 | 61 |
| K201780 | True Tulip System, True M.I.S. System | NKB | 2020-07-22 | 22 |
| K181584 | Redi-Spine | NKB | 2018-08-10 | 56 |
| K171559 | True Spinal Fixation System | NKB | 2017-07-24 | 55 |
| K170710 | True Spinal Fixation System | NKB | 2017-07-14 | 128 |
| K133690 | TRUE SPINAL FUSSION SYSTEM | MNH | 2014-05-07 | 156 |
| K130958 | TRUE SPINAL FIXATION SYSTEM | MNI | 2013-10-17 | 195 |
Recalls
openFDA lists no recalls under a recalling firm named Innovative Surgical Designs, 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.
- Innovative Health, LLC (50 510(k)s)
- Innovative Medical Systems, Inc. (22 510(k)s)
- Innovative Technologies , Ltd. (14 510(k)s)
- Innovative Surgical Products, Inc. (12 510(k)s)
- Innovative Diagnostic Systems, Inc. (11 510(k)s)
- Innovative Gloves Co;, Ltd. (9 510(k)s)
- Innovative Bioceramix, Inc. (8 510(k)s)
- Innovative Surgical, Inc. (7 510(k)s)
- Innovative Medical Technologies, Inc. (6 510(k)s)
- Innovative Spinal Technologies, Inc. (4 510(k)s)
- Innovative Therapies, Inc. (4 510(k)s)
- Innovative Trauma Care, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innovative Surgical Designs, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Innovative Surgical Designs, Inc.” (first 2013, latest 2022), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Innovative Surgical Designs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innovative Surgical Designs, Inc. is 128 days. Since 2017: 61 days, versus 68 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Innovative Surgical Designs, Inc.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 7); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1); MNI (Orthosis, Spinal Pedicle Fixation, 1).
Next steps
- See all 9 Innovative Surgical Designs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Innovative Surgical Designs, 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.