S.H.Pitkar Orthotools Pvt. , Ltd.: FDA clearances and approvals
S.H.Pitkar Orthotools Pvt. , Ltd. has 5 FDA 510(k) clearances (first 2019, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time: 200 days. Since 2017 its median was 200 days, against 88 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 230 |
| 2020 | 3 | 157 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 224 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, S.H.Pitkar Orthotools Pvt. , Ltd.'s cleared 510(k)s took a median 200 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent S.H.Pitkar Orthotools Pvt. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240233 | Pitkar Spinal Pedicle Screw System | NKB | 2024-09-09 | 224 |
| K200728 | Pitkar DeftFix System | KTT | 2020-10-06 | 200 |
| K200518 | Pitkar External Fixation System - Rail Mechanism | KTT | 2020-07-29 | 149 |
| K192619 | Pitkar Locked Plating System | HRS | 2020-02-27 | 157 |
| K190486 | Pitkar External Fixation System | KTT | 2019-10-16 | 230 |
Recalls
openFDA lists no recalls under a recalling firm named S.H.Pitkar Orthotools Pvt. , Ltd..
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 S.H.Pitkar Orthotools Pvt. , Ltd. have?
S.H.Pitkar Orthotools Pvt. , Ltd. has 5 FDA 510(k) clearances (first 2019, latest 2024), across 3 product codes in 1 review panel.
How long does FDA take to clear S.H.Pitkar Orthotools Pvt. , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across S.H.Pitkar Orthotools Pvt. , Ltd.'s cleared 510(k)s is 200 days. Since 2017: 200 days, versus 88 days for all cleared 510(k)s in the same product codes.
What devices does S.H.Pitkar Orthotools Pvt. , Ltd. make?
Its most frequent FDA product codes are KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 3); HRS (Plate, Fixation, Bone, 1); NKB (Thoracolumbosacral Pedicle Screw System, 1).
Has S.H.Pitkar Orthotools Pvt. , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching S.H.Pitkar Orthotools Pvt. , Ltd. Related entities may recall under other names.
Next steps
- See all 5 S.H.Pitkar Orthotools Pvt. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KTT, S.H.Pitkar Orthotools Pvt. , Ltd.'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.