VSP Orthopedics

GUDID 00816847022163

A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.

3D SYSTEMS, INC.

Custom-made orthopaedic surgical guide, non-sterile
Primary Device ID00816847022163
NIH Device Record Key70d02f91-e4cb-4440-9d39-72511114a9ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameVSP Orthopedics
Version Model NumberAutograft Tibia Cutting Guide
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
GS100816847022163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBFOrthopaedic Surgical Planning And Instrument Guides

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


[00816847022163]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-19
Device Publish Date2019-09-11

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00816847022491A three dimensional physical model depicting allograft specific modified anatomy. To be used as
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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
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00816847022231A physical template that is composed of patient's bony anatomy and allows for precise location o
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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
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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
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00816847021876A physical template that is composed of allograft bony anatomy and allows for precise location o
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00816847021555A physical template that is composed of patient's bony anatomy and allows for precise location o
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