Sgarlato Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Sgarlato Laboratories, Inc. makes
Sgarlato Laboratories, Inc. manufactures orthopedic and pain management devices, including toe implants for lesser toes and subtalar joints, continuous passive motion devices for metatarsophalangeal joints, threaded fixation pins, and goniometers for joint measurement. The company also produces pain control infusion pumps and flexible hinge implants for toe joints, as well as a dedicated pain-free pump system.
The portfolio includes devices classified under FDA Class I and Class II, with several products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry, and the company operates from the United States.
Catalogue
Sgarlato Lesser Toe Implant Ref K884739
Regimes: 510(k) Registry: 510(k)Pain Control Infusion Pump Ref K990101
Regimes: 510(k) Registry: 510(k)Lundeen Subtalar Peg Implant Ref K922292
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
First Mpj Continuous Passive Motion Device Ref K926262
Regimes: 510(k) Registry: 510(k)Sgarlato Flexible Hinge Toe Implant Ref K905795
Regimes: 510(k) Registry: 510(k)O'brien Goniometer Ref K926237
Regimes: 510(k) Registry: 510(k)Threaded Fixation Pin Ref K982931
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sgarlato Laboratories, Inc. have in the registry?
The registry currently lists 8 devices for Sgarlato Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sgarlato Laboratories, Inc.'s devices?
Among its 8 most recently registered devices, Sgarlato Laboratories, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Sgarlato Laboratories, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Sgarlato Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sgarlato Laboratories, Inc. in the registry?
The most recently registered devices listed for Sgarlato Laboratories, Inc. include SGARLATO LESSER TOE IMPLANT, PAIN CONTROL INFUSION PUMP, LUNDEEN SUBTALAR PEG IMPLANT and SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP.