VSP Orthopedics - A physical template that is composed of patient's - 3D SYSTEMS, INC.

Duns Number:085049749

Device Description: A physical template that is composed of patient's bony anatomy and allows for precise loca A physical template that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.

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More Product Details

Catalog Number

-

Brand Name

VSP Orthopedics

Version/Model Number

Autograft Pelvic Template

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

K190044

Product Code Details

Product Code

PBF

Product Code Name

Orthopaedic Surgical Planning And Instrument Guides

Device Record Status

Public Device Record Key

ac41af4e-7d15-44b6-ae3e-f7743800ea49

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

September 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3D SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 146