Depuy Ace Timax Calcaneal Peri-Articular Plate
FDA 510(k) K981775 · Depuy Ace Medical Co.
510(k) numberK981775
Submission
- Device name
- Depuy Ace Timax Calcaneal Peri-Articular Plate
- Applicant
- Depuy Ace Medical Co.
El Segundo, CA, US - Received
- May 20, 1998
- Decision date
- July 29, 1998
- 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 |
|---|---|---|
| K990392 | Depuy Ace Spider PlateHRS · Traditional | 03/23/1999SE |
| K990120 | Modification of Depuy Ace Timax Medial Pilon PlateHSB · Special | 02/01/1999SE |
| K984458 | Depuy Ace Spider PlateHRS · Traditional | 12/31/1998SE |
| K983853 | Depuy Ace Timax Meta PlateHRS · Traditional | 12/22/1998SE |
| K983265 | Depuy Ace Composite Locking NutHTN · Traditional | 10/26/1998SE |
| K982347 | Depuy Ace Timax Pilon PlateHRS · Traditional | 08/31/1998SE |
| K974245 | Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace Fixed Tip…LXT · Traditional | 05/22/1998SE |
| K970503 | Depuy Ace Trochanteric Side PlateHRS · Traditional | 04/30/1997SE |
| K970202 | Depuy Ace Aim Titanium Tibial NailHSB · Traditional | 03/21/1997SE |
Questions and answers
When was Depuy Ace Timax Calcaneal Peri-Articular Plate cleared by the FDA?
Depuy Ace Timax Calcaneal Peri-Articular Plate (K981775) received a 510(k) decision of Substantially Equivalent on July 29, 1998, 70 days after the submission was received.
What is the product code of K981775?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.