VSP Orthopedics

GUDID 00816847022538

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.

Surgical implant template, single-use

Primary Device ID	00816847022538
NIH Device Record Key	9b650543-8d88-4768-90eb-4524b8eaab2f
Commercial Distribution Status	In Commercial Distribution
Brand Name	VSP Orthopedics
Version Model Number	Orthopedic Implant Template
Company DUNS	085049749
Company Name	3D SYSTEMS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816847022538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K190044

FDA Product Code

PBF	Orthopaedic Surgical Planning And Instrument Guides

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00816847022538]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-09-19
Device Publish Date	2019-09-11

On-Brand Devices [VSP Orthopedics]

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