Axya Medical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 19
- FDA recalls
- 25
At a glance
Market reach
- United States
- FDA recalls
What Axya Medical, Inc. makes
Axya Medical, Inc. manufactures bone anchors for surgical fixation, including self-tapping, bio-absorbable, and nonabsorbable variants made from materials like titanium and polyester. Their portfolio also includes suture materials and a suture welding system with a J-tip design, as well as modification kits for bone anchors.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with most submissions recorded via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 19 devicesFDA recalls
FDA recall records list 25 recalls initiated by Axya Medical, Inc., initiated on 2007-09-27. By recorded status: 25 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 27 Sep 2007 Z-0331-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0332-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0333-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0334-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0335-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0336-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0337-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0338-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0339-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0340-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Show all 25 recalls
2007
- 27 Sep 2007 Z-0341-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0342-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0343-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0344-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0345-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0346-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0347-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0348-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0349-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0350-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0351-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0352-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0353-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0354-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
- 27 Sep 2007 Z-0355-2008 Unclassified (pre-2012) Terminated Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Frequently asked questions
How many devices does Axya Medical, Inc. have in the registry?
The registry currently lists 19 devices for Axya Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Axya Medical, Inc.'s devices?
Among its 19 most recently registered devices, Axya Medical, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do Axya Medical, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Axya Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Axya Medical, Inc.?
FDA recall records list 25 recalls initiated by Axya Medical, Inc., the most recent initiated on 2007-09-27. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Axya Medical, Inc. in the registry?
The most recently registered devices listed for Axya Medical, Inc. include MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000, AXYAFLEX POLYESTER SUTURE, AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR and AXYALOOP NONABSORBABLE BONE ANCHOR.