ORTHOLOC™ SPS

GUDID 00846832075010

TORNIER, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00846832075010
NIH Device Record Key224551a9-3eca-4e5f-b8e9-a89eee677720
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHOLOC™ SPS
Version Model NumberSPS448
Company DUNS968990812
Company NameTORNIER, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com

Device Dimensions

Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter
Outer Diameter3.5 Millimeter
Length48 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832075010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


[00846832075010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-01
Device Publish Date2019-09-23

On-Brand Devices [ORTHOLOC™ SPS]

00846832074020SPS00GT
00846832074013SPS010
00846832074006SPS007
00846832073993SPS005
00846832073726MHP006
00846832073702MHP004
00846832073689MHP002
00846832073672SPS356
00846832073665SPS354
00846832073658SPS352
00846832073641SPS350
00846832073634SPS348
00846832073627SPS346
00846832073610SPS344
00846832073603SPS342
00846832073597SPS340
00846832073580SPS338
00846832073573SPS336
00846832073566SPS334
00846832073559SPS332
00846832073542SPS330
00846832073535SPS328
00846832073528SPS326
00846832073511SPS324
00846832073504SPS322
00846832073498SPS320
00846832073481SPS318
00846832073474SPS316
00846832073467SPS256
00846832073450SPS254
00846832073443SPS252
00846832073436SPS250
00846832073429SPS248
00846832073412SPS246
00846832073405SPS244
00846832073399SPS242
00846832073382SPS240
00846832073375SPS238
00846832073368SPS236
00846832073351SPS234
00846832073344SPS232
00846832073337SPS230
00846832073320SPS228
00846832073313SPS226
00846832073306SPS224
00846832073290SPS222
00846832073283SPS220
00846832073276SPS218
00846832073269SPS216
00846832073252SPS156

Trademark Results [ORTHOLOC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHOLOC
ORTHOLOC
77636931 4222143 Live/Registered
Wright Medical Technology, Inc.
2008-12-19
ORTHOLOC
ORTHOLOC
73596966 1417357 Live/Registered
DOW CORNING CORPORATION
1986-05-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.