Outologous Spinal Fixation System PS7055

GUDID 00813892020892

7.0 X 55mm Titanium Pedicle Screw Self Tapping

Orthopedic Sciences Inc

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00813892020892
NIH Device Record Keye6d9c6a3-b138-49fa-ad97-8b8ac2297cda
Commercial Distribution StatusIn Commercial Distribution
Brand NameOutologous Spinal Fixation System
Version Model NumberPS7055
Catalog NumberPS7055
Company DUNS068109169
Company NameOrthopedic Sciences Inc
Device Count1
DM Exempttrue
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com
Phone+1(562)799-5550
Emailinfo@orthopedicsciences.com

Device Dimensions

Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter
Length55 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100813892020892 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

[00813892020892]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-13

On-Brand Devices [Outologous Spinal Fixation System]

00813892021073Cross Link Nut
00813892021066Cross Link Hook
0081389202105980mm Cross Link
0081389202104270mm Cross Link
0081389202103560mm Cross Link
0081389202102850mm Cross Link
0081389202101140mm Cross Link
00813892021004Set Screw
008138920209916.0 x 150mm Titanium Rod
008138920209846. 0x 120mm Titanium Rod
008138920209776.0 x 100mm Titanium Rod
008138920209606.0 x 90mm Titanium Rod
008138920209536.0 x 80mm Titanium Rod
008138920209466.0 x 70mm Titanium Rod
008138920209396.0 x 60mm Titanium Rod
008138920209226.0 x 50mm Titanium Rod
008138920209156.0 x 40mm Titanium Rod
008138920209087.0 X 60mm Titanium Pedicle Screw Self Tapping
008138920208927.0 X 55mm Titanium Pedicle Screw Self Tapping
008138920208857.0 X 50mm Titanium Pedicle Screw Self Tapping
008138920208787.0 X 45mm Titanium Pedicle Screw Self Tapping
008138920208617.0 X 40mm Titanium Pedicle Screw Self Tapping
008138920208547.0 X 35mm Titanium Pedicle Screw Self Tapping
008138920208477.0 X 30mm Titanium Pedicle Screw Self Tapping
008138920208306.0 X 60mm Titanium Pedicle Screw Self Tapping
008138920208236.0 X 55mm Titanium Pedicle Screw Self Tapping
008138920208166.0 X 50mm Titanium Pedicle Screw Self Tapping
008138920208096.0 X 45mmTitanium Pedicle Screw Self Tapping
008138920207936.0 X 40mm Titanium Pedicle Screw Self Tapping
008138920207866.0 X 35mm Titanium Pedicle Screw Self Tapping
008138920207796.0 X 30mm Titanium Pedicle Screw Self Tapping
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