PRECICE® Bone Transport System - Retrograde Femur 10° Bend, 10.0mm x 400mm, 5/10cm - NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Duns Number:837845234

Device Description: Retrograde Femur 10° Bend, 10.0mm x 400mm, 5/10cm ST

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More Product Details

Catalog Number

BT10-10A400-5

Brand Name

PRECICE® Bone Transport System

Version/Model Number

BT10-10A400-5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K182170

Product Code Details

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Device Record Status

Public Device Record Key

5753bcf1-ff4e-4e4c-bf95-62d34f8a1e54

Public Version Date

April 19, 2019

Public Version Number

1

DI Record Publish Date

April 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NUVASIVE SPECIALIZED ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 254
2 A medical device with a moderate to high risk that requires special controls. 2199