Company ยท US
Flower Orthopedics Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2020. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2020 | K192949 | Flower Suture Anchor Set Flower Orthopedics Corporation | MBI |
| Jun 6, 2017 | K170687 | Flower Bone Screw Set Flower Orthopedics Corporation | HWC |
| Sep 15, 2014 | K142306 | Flower Upper Extremity Plating Set Flower Orthopedics Corporation | HRS |
| Mar 27, 2014 | K133930 | FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET Flower Orthopedics Corporation | HRS |
| Nov 18, 2013 | K133102 | FLOWER ANKLE PLATING SET Flower Orthopedics Corporation | HRS |
| Oct 30, 2013 | K132248 | FLOWER BONE SCREW SET Flower Orthopedics Corporation | HWC |
| Aug 22, 2013 | K131657 | FLOWER SMALL AND MEDIUM IMPLANT SET Flower Orthopedics Corporation | HRS |
| Mar 29, 2013 | K123562 | FLOWER SMALL AND MEDIUM BONE IMPLANTS Flower Orthopedics Corporation | HRS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2023 | Flower Orthopedics Corporation Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is prov Open, Classified |
HSB | K202858 |
| Nov 2, 2021 | Flower Orthopedics Corporation Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail Syste Terminated |
HSB | K202858 |
| Sep 3, 2021 | Flower Orthopedics Corporation Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 Terminated |
HRS | K123562 |
| Sep 1, 2021 | Flower Orthopedics Corporation Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foo Terminated |
HTW | None listed |
| Sep 1, 2021 | Flower Orthopedics Corporation Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Se Terminated |
HTW | None listed |
| Sep 1, 2021 | Flower Orthopedics Corporation Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism.
Catalog Terminated |
HTW | None listed |
| Sep 1, 2021 | Flower Orthopedics Corporation Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small lo Terminated |
HTW | None listed |
| Apr 15, 2021 | Flower Orthopedics Corporation T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5 Terminated |
HXX | None listed |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the cal Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calca Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calca Terminated |
HRS | K133930 |
| Dec 22, 2016 | Flower Orthopedics Corporation Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set. Terminated |
LXH | None listed |
| Mar 24, 2015 | Flower Orthopedics Corporation Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Terminated |
HWC | K123562 K131657 |