Emerge Medical Small and Large Non-locking Fragment Plate System

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

510(k) Number

K133541 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Emerge Medical Bone Plate System

  Class II

  FDA 510(k) K133536 Active Cleared 26 Feb 2014

• Emerge Medical Locking One-Third Tubular Plate System

  Class II

  FDA 510(k) K131480 Active Cleared 3 Jul 2013

• Emerge Medical Periarticular and Locking Large Fragment System

  Class II

  FDA 510(k) K140119 Active Cleared 12 Mar 2014

• Emerge External Fixation System

  Class II

  FDA 510(k) K140675 Active Cleared 10 Jun 2014

• Emerge Medical Cannulated Screw Fixation System

  Class II

  FDA 510(k) K102343 Active Cleared 23 Nov 2010

• Emerge Medical Small Fragment Locked Plating System

  Class II

  FDA 510(k) K133452 Active Cleared 8 Jan 2014

See all devices from Emerge Medical →

• What is the Emerge Medical Small and Large Non-locking Fragment Plate System used for?

  The Emerge Medical Small and Large Non-locking Fragment Plate System is intended for use in fractures, osteotomies, nonunions, deformities, revisions, and replantations of bones and bone fragments, including the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, tarsals, metatarsals, phalanges, and calcaneus, including in osteoporotic bone, as it provides fixation for small and large bone fragments in orthopedic surgical settings.

• How is the Emerge Medical Small and Large Non-locking Fragment Plate System supplied and what is its sterility status?

  The device data does not specify whether the Emerge Medical Small and Large Non-locking Fragment Plate System is supplied sterile or non-sterile, or in single-use or reusable format; therefore, sterility and reuse status cannot be determined from the provided information.

• What sizes or models are available for the Emerge Medical Small and Large Non-locking Fragment Plate System?

  The device data does not list specific sizes, models, or reference numbers for the Emerge Medical Small and Large Non-locking Fragment Plate System; only the system name is provided, so no details on available sizes or models can be given.

• What are the storage requirements for the Emerge Medical Small and Large Non-locking Fragment Plate System?

  The device data does not include any storage conditions or requirements for the Emerge Medical Small and Large Non-locking Fragment Plate System, so storage specifications cannot be determined from the provided information.

• What regulatory pathway was used for the Emerge Medical Small and Large Non-locking Fragment Plate System?

  The Emerge Medical Small and Large Non-locking Fragment Plate System received FDA 510(k) clearance (K133541) on January 28, 2014, and is classified as a Class II medical device with Special Controls under the HRS product code as a Plate, Fixation, Bone.