Integra® BioMotion® Cannulated Hemi System - The Integra BioMotion Cannulated Hemi System is a - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Integra BioMotion Cannulated Hemi System is a partial joint replacement system for the The Integra BioMotion Cannulated Hemi System is a partial joint replacement system for the first metatarsophalangeal joint (MPJ). Implants are available in sizes ranging from 15mm to 23mm. The system includes instruments to facilitate the placement of the implants. All implants are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The BioMotion hemi implant is indicated for use in the treatment of degenerative arthritis in the first MPJ along with hallux limitus/rigidus, hallux valgus and pain or instability.

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More Product Details

Catalog Number

BIOMOTIONIMP

Brand Name

Integra® BioMotion® Cannulated Hemi System

Version/Model Number

BIOMOTIONIMP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K083469

Product Code Details

Product Code

KWD

Product Code Name

PROSTHESIS, TOE, HEMI-, PHALANGEAL

Device Record Status

Public Device Record Key

b55a5fca-ed68-49ed-b47b-42f8fe058f17

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

October 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASCENSION ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1909
2 A medical device with a moderate to high risk that requires special controls. 1404
3 A medical device with high risk that requires premarket approval 12
U Unclassified 15