Emerge Medical Small Fragment Locked Plating System
FDA 510(k) K133452 · Emerge Medical
510(k) numberK133452
Submission
- Device name
- Emerge Medical Small Fragment Locked Plating System
- Applicant
- Emerge Medical
Denver, CO, US - Received
- November 12, 2013
- Decision date
- January 8, 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 |
|---|---|---|
| K141347 | Emerge Medical Im Nail SystemHSB · Traditional | 10/02/2014SE |
| K140675 | Emerge External Fixation SystemKTT · Traditional | 06/10/2014SE |
| K140107 | Emerge Medical Distal Radius SetHRS · Traditional | 03/13/2014SE |
| K140119 | Emerge Medical Periarticular and Locking Large Fragment SystemHRS · Traditional | 03/12/2014SE |
| K140098 | Emerge Medical Small Fragment Locked Plating SystemHRS · Traditional | 03/12/2014SE |
| K133536 | Emerge Medical Bone Plate SystemHRS · Traditional | 02/26/2014SE |
| K133541 | Emerge Medical Small and Large Non-Locking Fragment Plate SystemHRS · Traditional | 01/28/2014SE |
| K131480 | Emerge Medical Locking One-Third Tubular Plate SystemHRS · Traditional | 07/03/2013SE |
| K122489 | Emerge Medical Solid Bone ScrewsHWC · Traditional | 12/10/2012SE |
| K102343 | Emerge Medical Cannulated Screw Fixation SystemHWC · Traditional | 11/23/2010SE |
Questions and answers
When was Emerge Medical Small Fragment Locked Plating System cleared by the FDA?
Emerge Medical Small Fragment Locked Plating System (K133452) received a 510(k) decision of Substantially Equivalent on January 8, 2014, 57 days after the submission was received.
What is the product code of K133452?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.