Duns Number:942377524
Device Description: The Integra Silicone PIP is intended for replacement of the proximal interphalangeal (PIP) The Integra Silicone PIP is intended for replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. This set includes silicone PIP trials to evaluate size and fit of the implants. Instruments are also included.
Catalog Number
-
Brand Name
Integra®
Version/Model Number
SILPIPINSTP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
KYJ
Product Code Name
PROSTHESIS, FINGER, CONSTRAINED, POLYMER
Public Device Record Key
35a510a8-206f-42bf-a5b7-3f4e6c2be56a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 03, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |