Flower Orthopedics Corporation: FDA clearances and approvals
Flower Orthopedics Corporation has 8 FDA 510(k) clearances (first 2013, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time: 92 days. openFDA lists 16 product recalls by a recalling firm named Flower Orthopedics Corporation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 4 | 90 |
| 2014 | 2 | 60 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 91 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 355 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Flower Orthopedics Corporation's cleared 510(k)s took a median 223 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 5 | 5 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Flower Orthopedics Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192949 | Flower Suture Anchor Set | MBI | 2020-10-07 | 355 |
| K170687 | Flower Bone Screw Set | HWC | 2017-06-06 | 91 |
| K142306 | Flower Upper Extremity Plating Set | HRS | 2014-09-15 | 27 |
| K133930 | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET | HRS | 2014-03-27 | 94 |
| K133102 | FLOWER ANKLE PLATING SET | HRS | 2013-11-18 | 49 |
| K132248 | FLOWER BONE SCREW SET | HWC | 2013-10-30 | 103 |
| K131657 | FLOWER SMALL AND MEDIUM IMPLANT SET | HRS | 2013-08-22 | 77 |
| K123562 | FLOWER SMALL AND MEDIUM BONE IMPLANTS | HRS | 2013-03-29 | 130 |
Recalls
16 product recalls in 8 recall events; 2 initiated in the last five years. Most recent: 2023-08-29.
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 Flower Orthopedics Corporation have?
Flower Orthopedics Corporation has 8 FDA 510(k) clearances (first 2013, latest 2020), across 3 product codes in 1 review panel.
How long does FDA take to clear Flower Orthopedics Corporation's 510(k)s?
The median time from FDA receipt to decision across Flower Orthopedics Corporation's cleared 510(k)s is 92 days.
What devices does Flower Orthopedics Corporation make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 5); HWC (Screw, Fixation, Bone, 2); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 1).
Has Flower Orthopedics Corporation had device recalls?
openFDA lists 16 product recalls in 8 recall events by a recalling firm whose name matches Flower Orthopedics Corporation; the most recent began 2023-08-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 8 Flower Orthopedics Corporation clearances with predicates and recalls
- Run predicate analysis for product code HRS, Flower Orthopedics Corporation'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.