Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating Set
FDA 510(k) K133930 · Flower Orthopedics Corporation
510(k) numberK133930
Submission
- Device name
- Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating Set
- Applicant
- Flower Orthopedics Corporation
Horsham, PA, US - Received
- December 23, 2013
- Decision date
- March 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K192949 | Flower Suture Anchor SetMBI · Traditional | 10/07/2020SE |
| K170687 | Flower Bone Screw SetHWC · Special | 06/06/2017SE |
| K142306 | Flower Upper Extremity Plating SetHRS · Traditional | 09/15/2014SE |
| K133102 | Flower Ankle Plating SetHRS · Traditional | 11/18/2013SE |
| K132248 | Flower Bone Screw SetHWC · Traditional | 10/30/2013SE |
| K131657 | Flower Small and Medium Implant SetHRS · Special | 08/22/2013SE |
| K123562 | Flower Small and Medium Bone ImplantsHRS · Traditional | 03/29/2013SE |
Questions and answers
When was Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating Set cleared by the FDA?
Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating Set (K133930) received a 510(k) decision of Substantially Equivalent on March 27, 2014, 94 days after the submission was received.
What is the product code of K133930?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.