Axyaloop Nonabsorbable Bone Anchor
FDA 510(k) K060970 · Axya Medical, Inc.
510(k) numberK060970
Submission
- Device name
- Axyaloop Nonabsorbable Bone Anchor
- Applicant
- Axya Medical, Inc.
Beverly, MA, US - Received
- April 7, 2006
- Decision date
- July 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
More from Novastep
| 510(k) | Device | Decision |
|---|---|---|
| K070773 | Axya, Model 3000 Axyzloop Titanium Bone AnchorMBI · Traditional | 10/11/2007SE |
| K070253 | Axya Suture Welding System and KitGAT · Traditional | 07/11/2007SE |
| K063194 | Tufflex Polyester SutureGAT · Special | 12/04/2006SE |
| K060165 | Axyaflex Polyester SutureGAT · Traditional | 09/01/2006SE |
| K052491 | Axya Model 6500 Axyaloop Self-Tapping Bone AnchorMBI · Special | 10/07/2005SE |
| K051983 | Model 3000 Axyaloop Bio-Absorbable Bone AnchorMAI · Special | 08/05/2005SE |
| K051250 | Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorMAI · Special | 06/09/2005SE |
| K041698 | Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorMAI · Traditional | 10/05/2004SE |
| K022207 | Axya Model 3000 Axyaloop Titanium Bone Anchor SystemMBI · Traditional | 10/04/2002SE |
| K021929 | Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical SystemLFL · Traditional | 09/10/2002SE |
Questions and answers
When was Axyaloop Nonabsorbable Bone Anchor cleared by the FDA?
Axyaloop Nonabsorbable Bone Anchor (K060970) received a 510(k) decision of Substantially Equivalent on July 5, 2006, 89 days after the submission was received.
What is the product code of K060970?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.