Bilok® Screw - The Bilok® Tapered Screw is a cannulated, - BIOCOMPOSITES LTD

Duns Number:424382307

Device Description: The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorb The Bilok® Tapered Screw is a cannulated, sterile, single-use bone screw made of an absorbable Poly (L-lactic) acid and calcium phosphate which will gradually be absorbed into the body over a period of 24 months. This function however is patient dependant. The Bilok° Screw provides an interference fixation during femoral and/or tibial fixation in ACL reconstruction that resorbs and is replaced with bone during the healing process. Bilok® Screws are biodegradable and biocompatible.

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More Product Details

Catalog Number

160-930T

Brand Name

Bilok® Screw

Version/Model Number

160-930T

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 02, 2020

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

-

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

c0640774-f22d-4164-b998-5809dfb6f0fe

Public Version Date

November 02, 2020

Public Version Number

3

DI Record Publish Date

June 30, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOCOMPOSITES LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 89