Custom Spine, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 22
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Custom Spine, Inc. makes
Custom Spine, Inc. manufactures bone-screw internal spinal fixation systems, including non-sterile devices for surgical spinal stabilization. Examples include the SECURIS system, ISSYS LP, PATHWAY AVID, PATHWAY ELIF, and KOMPREDA, designed for spinal fixation applications.
These devices are regulated under FDA Class II and Class U classifications, with submissions recorded in the FDA 510(k) and UDI registries. The company is based in the United States.
Catalogue
Search and filter all 22 devicesCompany details
- DUNS number
- 789071144
- [email protected]
- Phone
- 973-808-0019
FDA recalls
FDA recall records list 1 recall initiated by Custom Spine, Inc., initiated on 2013-03-28. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 28 Mar 2013 Z-1819-2013 Class II Terminated On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.
Frequently asked questions
How many devices does Custom Spine, Inc. have in the registry?
The registry currently lists 22 devices for Custom Spine, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Custom Spine, Inc.'s devices?
Among its 22 most recently registered devices, Custom Spine, Inc. has devices listed in FDA 510(k) (14 devices) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Custom Spine, Inc.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for Custom Spine, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Custom Spine, Inc.?
FDA recall records list 1 recall initiated by Custom Spine, Inc., the most recent initiated on 2013-03-28. 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 Custom Spine, Inc. in the registry?
The most recently registered devices listed for Custom Spine, Inc. include SECURIS 115160, SECURIS 115120, SECURIS 115080 and SECURIS 115540.