Acumed Clavicle Screw System
FDA 510(k) K083144 · Acumed, LLC
510(k) numberK083144
Submission
- Device name
- Acumed Clavicle Screw System
- Applicant
- Acumed, LLC
Hillsboro, OR, US - Received
- October 23, 2008
- Decision date
- June 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDW – Pin, Fixation, Threaded
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmJDW · Special | Biodynamik, Inc. | 02/10/2026SE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) SystemJDW · Traditional | Meduloc, LLC | 10/29/2025SE |
| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
| K223112 | MAVERICK Mini External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 12/08/2022SE |
| K213874 | MAVERICK External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 02/11/2022SE |
| K211508 | Steinmann Pins and Kirschner WiresJDW · Traditional | Stryker GmbH | 10/05/2021SE |
| K210784 | Extended HA Half PinsJDW · Special | Smith & Nephew, Inc. | 04/02/2021SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | Syntec Scientific Corporation | 05/05/2020SE |
| K191803 | Orthopedic Fixation PinJDW · Traditional | Tinavi (Anhui) Medical Technologies Co., Ltd. | 04/14/2020SE |
| K192768 | Temporary Fixation PinsJDW · Traditional | Eisertech, LLC | 12/26/2019SE |
More from Eisertech, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm ScrewsHRS · Special | 08/21/2025SE |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsHRS · Abbreviated | 07/14/2025SE |
| K251296 | The Acumed Wrist Fixation SystemHRS · Traditional | 06/18/2025SE |
| K243624 | Acu-Sinch Knotless MiniHTN · Traditional | 01/23/2025SE |
| K233311 | Acumed Wrist Plating SystemHRS · Traditional | 04/22/2024SE |
| K230744 | Acumed Acutrak 3 Headless Compression Screw SystemHWC · Traditional | 06/09/2023SE |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalHWC · Traditional | 12/29/2022SE |
| K212990 | Acumed Ankle Syndesmosis Repair SystemHTN · Traditional | 01/07/2022SE |
| K210750 | Acumed Clavicle Hook Plating SystemHRS · Traditional | 07/15/2021SE |
| K151886 | Acumed Ankle and Small Fragment Base Set UpdateHRS · Traditional | 10/30/2015SE |
Questions and answers
When was Acumed Clavicle Screw System cleared by the FDA?
Acumed Clavicle Screw System (K083144) received a 510(k) decision of Substantially Equivalent on June 16, 2009, 236 days after the submission was received.
What is the product code of K083144?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.