VSP Orthopedics

GUDID 00816847022484

A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

3D SYSTEMS, INC.

Custom-made organ/bone anatomy model
Primary Device ID00816847022484
NIH Device Record Keycad7f874-c226-45b0-bc86-e9bd6c35affb
Commercial Distribution StatusIn Commercial Distribution
Brand NameVSP Orthopedics
Version Model NumberResected Patient Orthopedic Model
Company DUNS085049749
Company Name3D SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816847022484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBFOrthopaedic Surgical Planning And Instrument Guides

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

[00816847022484]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-27
Device Publish Date2019-09-11

On-Brand Devices [VSP Orthopedics]

00816847022552A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847022545Reusable accessory drill guide
00816847022538A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847022521A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847022514A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847022507A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847022491A three dimensional physical model depicting allograft specific modified anatomy. To be used as
00816847022484A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847022477A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847022460A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847022453A three dimensional physical model depicting allograft specific modified anatomy. To be used as
00816847022446A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847022231A physical template that is composed of patient's bony anatomy and allows for precise location o
00816847022224A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847022217A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847022200A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847022194A physical template that is composed of patient's bony anatomy and allows for precise location o
00816847022187A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847022170A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847022163A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847022156A physical template that is composed of patient's bony anatomy and allows for precise location o
00816847022149A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847022132A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847022125A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847021913A physical template that is composed of allograft bony anatomy and allows for precise location o
00816847021906A physical guide that is composed of allograft bony anatomy and allows for precise location of p
00816847021890A physical guide that is composed of allograft bony anatomy and allows for precise location of p
00816847021883A physical guide that is composed of allograft bony anatomy and allows for precise location of p
00816847021876A physical template that is composed of allograft bony anatomy and allows for precise location o
00816847021869A physical guide that is composed of allograft bony anatomy and allows for precise location of p
00816847021852A physical guide that is composed of allograft bony anatomy and allows for precise location of p
00816847021845A physical guide that is composed of allograft bony anatomy and allows for precise location of p
00816847021838A physical template that is composed of allograft bony anatomy and allows for precise location o
00816847021821A physical guide that is composed of allograft bony anatomy and allows for precise location of p
00816847021814A physical guide that is composed of allograft bony anatomy and allows for precise location of p
00816847021807A physical guide that is composed of allograft bony anatomy and allows for precise location of p
00816847021593A physical template that is composed of patient's bony anatomy and allows for precise location o
00816847021586A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847021579A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847021562A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847021555A physical template that is composed of patient's bony anatomy and allows for precise location o
00816847021548A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847021531A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847021524A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847021517A physical template that is composed of patient's bony anatomy and allows for precise location o
00816847021500A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847021494A physical guide that is composed of patient's bony anatomy and allows for precise location of p
00816847021487A physical guide that is composed of patient's bony anatomy and allows for precise location of p
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