Allofix Anchor, 5.0 MM Anchor
FDA 510(k) K061498 · Musculoskeletal Transplant Foundation
510(k) numberK061498
Submission
- Device name
- Allofix Anchor, 5.0 MM Anchor
- Applicant
- Musculoskeletal Transplant Foundation
Edison, NJ, US - Received
- May 31, 2006
- Decision date
- July 6, 2006
- 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 |
|---|---|---|
| K181633 | MTF Pre-Sutured TendonGAT · Traditional | 03/15/2019SE |
| K121313 | MTF New Bone Void FillerMQV · Traditional | 01/11/2013SE |
| K120479 | MTF FasciaOWY · Traditional | 11/08/2012SE |
| K113167 | MTF New Bone Voild FillerMQV · Traditional | 01/24/2012SE |
| K110003 | MTF New Bone Void FillerMQV · Traditional | 10/13/2011SE |
| K103795 | DBX Demineralized Bone Matrix PuttyMQV · Traditional | 04/13/2011SE |
| K103784 | DBX Demineralized Bone Matrix PuttyMQV · Traditional | 04/13/2011SE |
| K091217 | DBX Demineralized Bone Matrix PuttyNUN · Traditional | 10/02/2009SE |
| K091218 | DBX Demineralized Bone Matrix PuttyMQV · Traditional | 09/28/2009SE |
| K080399 | DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix PasteMBP · Traditional | 10/10/2008SE |
Questions and answers
When was Allofix Anchor, 5.0 MM Anchor cleared by the FDA?
Allofix Anchor, 5.0 MM Anchor (K061498) received a 510(k) decision of Substantially Equivalent on July 6, 2006, 36 days after the submission was received.
What is the product code of K061498?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.