Ace and Ace/Fischer Pre-Drill Pin System
FDA 510(k) K875021 · Buckman Co., Inc.
510(k) numberK875021
Submission
- Device name
- Ace and Ace/Fischer Pre-Drill Pin System
- Applicant
- Buckman Co., Inc.
Martinez, CA, US - Received
- December 4, 1987
- Decision date
- December 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K961320 | Cross Medical Bone Plate System/ CM Bone Plate System/Cross Ti Bone Plate SystemHWC · Traditional | 06/25/1998SE |
| K974641 | Futurelase 3000/3002 Erbium Laser SystemGEX · Traditional | 06/08/1998SE |
| K964252 | OrthochuckGEY · Traditional | 05/27/1997SE |
| K950099 | Synergy(Tm) Ti Posterior Spinal SystemMNH · Traditional | 01/16/1997SN |
| K960451 | Webb-Morley Spine SystemMNH · Traditional | 04/18/1996SN |
| K950999 | KSF Posterior Spingal Fixator for Severe SpondylolisthesisMNH · Traditional | 01/25/1996SE |
| K945756 | Imagn(Tm) 2000 SystemGKZ · Traditional | 12/19/1995SE |
| K940003 | Volumet CD4 + and CD8 + T Lymphocyte Count Test KitGKZ · Traditional | 10/19/1995SE |
| K951117 | Lihtan 532 LaserGEX · Traditional | 10/18/1995SE |
| K942751 | Vanguard Series Gas RegulatorsCAN · Traditional | 02/09/1995SE |
Questions and answers
When was Ace and Ace/Fischer Pre-Drill Pin System cleared by the FDA?
Ace and Ace/Fischer Pre-Drill Pin System (K875021) received a 510(k) decision of Substantially Equivalent on December 30, 1987, 26 days after the submission was received.
What is the product code of K875021?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.