Integra® - The Integra PyroCarbon PIP is indicated for use - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Integra PyroCarbon PIP is indicated for use in arthroplasty of the proximal interphala The Integra PyroCarbon PIP is indicated for use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction, and when the patient needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/dislocation secondary to damage or destruction of the articular cartilage. This set includes proximal and distal trials to evaluate proper size and fit of the implants. Instruments are included for assistance.

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More Product Details

Catalog Number

-

Brand Name

Integra®

Version/Model Number

PYROPIPINSTP

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

-

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

K082231

Product Code Details

Product Code

KYJ

Product Code Name

PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Device Record Status

Public Device Record Key

d306ce84-013e-44d0-88ea-237d3a3496e4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 15, 2016

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