Osteotec Silicone Finger Implant - Size 5 - The Osteotec Silicone Finger Implant is a - OSTEOTEC LIMITED

Duns Number:348489386

Device Description: The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant w The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty.

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More Product Details

Catalog Number

OSTF-5

Brand Name

Osteotec Silicone Finger Implant - Size 5

Version/Model Number

OSTF-5

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

K140453

Product Code Details

Product Code

KYJ

Product Code Name

Prosthesis, Finger, Constrained, Polymer

Device Record Status

Public Device Record Key

d80fce3e-439d-4d02-ba2f-a4bc2b36a58c

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSTEOTEC LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 11