External Fixation Anchor Pin
FDA 510(k) K001228 · Immedica, Inc.
510(k) numberK001228
Submission
- Device name
- External Fixation Anchor Pin
- Applicant
- Immedica, Inc.
Chatham, NJ, US - Received
- April 17, 2000
- Decision date
- July 7, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K023575 | Concert CranioplastGXP · Traditional | 01/22/2003SE |
| K013755 | Concert Radiopaque Bone CementLOD · Traditional | 02/08/2002SE |
| K003205 | Transfx Angled RodsLXT · Traditional | 12/15/2000SE |
| K001084 | Trans FX Adjustable Pin to Bar ClampLXT · Traditional | 06/15/2000SE |
| K991723 | Transfx Multi Pin ClampLXT · Traditional | 07/22/1999SE |
| K990848 | Transfx Intermediate External Fixation System,Transfx Small External Fixation System…LXT · Traditional | 05/17/1999SE |
| K984357 | Transfx External Fixation SystemLXT · Traditional | 03/04/1999SE |
Questions and answers
When was External Fixation Anchor Pin cleared by the FDA?
External Fixation Anchor Pin (K001228) received a 510(k) decision of Substantially Equivalent on July 7, 2000, 81 days after the submission was received.
What is the product code of K001228?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.