Lundeen Subtalar Peg Implant

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922292 ↗

FDA Product Code

MJW

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Sgarlato Lesser Toe Implant

  Class II

  FDA 510(k) K884739 Active Cleared 18 May 1989

• Pain Control Infusion Pump

  Class II

  FDA 510(k) K990101 Active Cleared 19 Mar 1999

• Sgarlato Labs Painfree Pump and Pain Control Infusion Pump

  Class II

  FDA 510(k) K043204 Active Cleared 30 Mar 2005

• First Mpj Continuous Passive Motion Device

  Class I

  FDA 510(k) K926262 Active Cleared 26 Jan 1994

• Sgarlato Flexible Hinge Toe Implant

  Class II

  FDA 510(k) K905795 Active Cleared 29 May 1991

• O'brien Goniometer

  Class I

  FDA 510(k) K926237 Active Cleared 2 Aug 1993

See all devices from Sgarlato Laboratories, Inc. →

• What is the Lundeen Subtalar Peg Implant used for?

  The Lundeen Subtalar Peg Implant is a type of orthopedic implant, specifically a prosthesis, subtalar, plug, polymer device, used to replace or support the subtalar joint in the foot.

• Is the Lundeen Subtalar Peg Implant supplied in different sizes?

  Yes, the device is available in different sizes to accommodate various patient needs.

• What is the regulatory status of the Lundeen Subtalar Peg Implant?

  The device has FDA 510(k) authorization, indicating it is substantially equivalent to a predicate device, and is classified as a class 2 device with a regulation number of 888.3040.