Alphatec Wire External Fixation System
FDA 510(k) K980788 · Alphatec Mfg., Inc.
510(k) numberK980788
Submission
- Device name
- Alphatec Wire External Fixation System
- Applicant
- Alphatec Mfg., Inc.
Palm Desert, CA, US - Received
- March 2, 1998
- Decision date
- May 22, 1998
- 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 |
|---|---|---|
| K033090 | Icon Polyaxial Pedicle Screw SystemKWP · Traditional | 03/26/2004SE |
| K023299 | Alpha Mirage Top Tightening Spinal SystemMNI · Traditional | 12/11/2002SE |
| K020356 | Alpha Mirage Top Tightening Spinal SystemMNH · Traditional | 07/23/2002SE |
| K993513 | Deltaloc Anterior Cervical Plate SystemKWQ · Traditional | 04/26/2000SE |
| K993873 | Alphatec External Fixation System Compression/Distraction RodKTT · Traditional | 01/03/2000SE |
| K992350 | Pylon Intramedullaary Nail SystemHSB · Traditional | 09/22/1999SE |
| K964400 | Alphatec External Fixation SystemKTT · Traditional | 04/28/1997SE |
| K951846 | Mirage Spinal System for Severe SpondylolisthesisKWP · Traditional | 02/14/1996SN |
| K926417 | Alphatec 130-150 Slotted Compression Hip ScrewKTT · Traditional | 09/28/1994SE |
| K930515 | Alpha Spinal SystemKWP · Traditional | 06/29/1994SESK |
Questions and answers
When was Alphatec Wire External Fixation System cleared by the FDA?
Alphatec Wire External Fixation System (K980788) received a 510(k) decision of Substantially Equivalent on May 22, 1998, 81 days after the submission was received.
What is the product code of K980788?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.