Alphatec Mfg., Inc.
United StatesFDA applicant, unverified
- Devices
- 20
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Alphatec Mfg., Inc. makes
Alphatec Mfg., Inc. manufactures orthopedic fixation devices, including polyaxial pedicle screws, spinal tightening systems, external fixation hardware, cortical lag screws, compression plates, and intramedullary nails. Their portfolio also covers cervical plates, small fragment surgical tools, cannulated bone screws, and distraction/rod systems for bone stabilization.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. Products are listed in the FDA’s 510(k) registry, reflecting compliance with US medical device standards. The manufacturer operates from the United States.
Catalogue
Search and filter all 20 devicesFDA recalls
FDA recall records list 1 recall initiated by Alphatec Mfg., Inc., initiated on 2002-05-30. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2002
- 30 May 2002 Z-0949-03 Unclassified (pre-2012) Terminated Laser marking is wrong on bone screws, says 40 and is 45 mm long.
Frequently asked questions
How many devices does Alphatec Mfg., Inc. have in the registry?
The registry currently lists 20 devices for Alphatec Mfg., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alphatec Mfg., Inc.'s devices?
Among its 20 most recently registered devices, Alphatec Mfg., Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Alphatec Mfg., Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Alphatec Mfg., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Alphatec Mfg., Inc.?
FDA recall records list 1 recall initiated by Alphatec Mfg., Inc., the most recent initiated on 30 May 2002. 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 Alphatec Mfg., Inc. in the registry?
The most recently registered devices listed for Alphatec Mfg., Inc. include ICON POLYAXIAL PEDICLE SCREW SYSTEM, ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM, ALPHATEC WIRE EXTERNAL FIXATION SYSTEM and ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW.