Tac' Pin
FDA 510(k) K993910 · New Deal, S.A.
510(k) numberK993910
Submission
- Device name
- Tac' Pin
- Applicant
- New Deal, S.A.
Potomac, MD, US - Received
- November 17, 1999
- Decision date
- February 1, 2000
- 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 |
|---|---|---|
| K070241 | Modification to Lapidus PlateHRS · Special | 02/08/2007SE |
| K070160 | Modification to TTC PlatesHRS · Special | 02/08/2007SE |
| K063820 | Lisfranc PlateHRS · Special | 02/08/2007SE |
| K060474 | Lisfranc PlateHRS · Traditional | 08/03/2006SE |
| K061765 | Kalix II ImplantHWC · Special | 07/18/2006SE |
| K061594 | Large Uni-Clip StapleJDR · Special | 07/03/2006SE |
| K060476 | Lapidus PlateHRS · Traditional | 05/17/2006SE |
| K060473 | TTC PlateHRS · Traditional | 05/17/2006SE |
| K053093 | Kalix II Implant, Model 141 0XX with XXHWC · Special | 12/07/2005SE |
| K052152 | B-Bop PlateHRS · Traditional | 09/13/2005SE |
Questions and answers
When was Tac' Pin cleared by the FDA?
Tac' Pin (K993910) received a 510(k) decision of Substantially Equivalent on February 1, 2000, 76 days after the submission was received.
What is the product code of K993910?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.