Mini Fragment Plate
FDA 510(k) K934614 · Onyx Medical Corp.
510(k) numberK934614
Submission
- Device name
- Mini Fragment Plate
- Applicant
- Onyx Medical Corp.
Memphis, TN, US - Received
- September 27, 1993
- Decision date
- May 4, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K041679 | Cold Light; Cold Light MD; Gossamer DermlightILY · Abbreviated | 12/16/2004SE |
| K942022 | Face-It ShieldLYU · Traditional | 07/08/1994SE |
| K931690 | Spoon PlateHRS · Traditional | 06/07/1994SN |
| K931692 | T-PlateHRS · Traditional | 05/04/1994SN |
| K931684 | Epiphysis PlateHRS · Traditional | 05/04/1994SN |
| K931680 | Cannulated Cancellous ScrewHWC · Traditional | 05/04/1994SN |
| K934616 | Cancellous Bone ScrewHWC · Traditional | 04/25/1994SN |
| K934615 | Cancellous Bone ScrewHWC · Traditional | 04/25/1994SN |
| K931790 | Cortical Bone ScrewHWC · Traditional | 04/25/1994SN |
| K931694 | 1/4 Tubular PlateHRS · Traditional | 04/25/1994SN |
Questions and answers
When was Mini Fragment Plate cleared by the FDA?
Mini Fragment Plate (K934614) received a 510(k) decision of Substantially Equivalent for Some Indications on May 4, 1994, 219 days after the submission was received.
What is the product code of K934614?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.