SPIRA-L

GUDID B030SPL1020060

Trial, Bi-Convex, Parallel, 22 x 60mm, 8mm

CAMBER SPINE TECHNOLOGIES, LLC

Spinal implant trial
Primary Device IDB030SPL1020060
NIH Device Record Key3a52fa3a-fd9c-4798-9680-b16159b1bac2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPIRA-L
Version Model NumberSPL-102-006
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030SPL1020060 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


[B030SPL1020060]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-01
Device Publish Date2022-11-23

On-Brand Devices [SPIRA-L]

B031SPL1020020Trial, Bi-Convex, Parallel, 18 x 60mm, 10mm
B030SPL226015080Bi-Convex, 15° Lordotic, 22 x 60mm, 8mm
B030SPL225515080Bi-Convex, 15° Lordotic, 22 x 55mm, 8mm
B030SPL225015080Bi-Convex, 15° Lordotic, 22 x 50mm, 8mm
B030SPL224515080Bi-Convex, 15° Lordotic, 22 x 45mm, 8mm
B030SPL224015080Bi-Convex, 15° Lordotic, 22 x 40mm, 8mm
B030SPL1020380Trial, Bi-Convex, 15° Lordotic, 22 x 60mm, 14mm
B030SPL1020370Trial, Bi-Convex, 15° Lordotic, 22 x 60mm, 12mm
B030SPL1020360Trial, Bi-Convex, 15° Lordotic, 22 x 60mm, 10mm
B030SPL1020350Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 16mm
B030SPL1020340Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 14mm
B030SPL1020330Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 12mm
B030SPL1020320Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 10mm
B030SPL1020310Trial, Bi-Convex, 15° Lordotic, 18 x 60mm, 8mm
B030SPL1020300Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 16mm
B030SPL1020290Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 14mm
B030SPL1020280Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 12mm
B030SPL1020270Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 10mm
B030SPL1020260Trial, Bi-Convex, 8° Lordotic, 26 x 60mm, 8mm
B030SPL1020250Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 16mm
B030SPL1020240Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 14mm
B030SPL1020230Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 12mm
B030SPL1020220Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 10mm
B030SPL1020210Trial, Bi-Convex, 8° Lordotic, 22 x 60mm, 8mm
B030SPL1020200Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 16mm
B030SPL1020190Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 14mm
B030SPL1020180Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 12mm
B030SPL1020170Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 10mm
B030SPL1020160Trial, Bi-Convex, 8° Lordotic, 18 x 60mm, 8mm
B030SPL1020150Trial, Bi-Convex, Parallel, 26 x 60mm, 16mm
B030SPL1020140Trial, Bi-Convex, Parallel, 26 x 60mm, 14mm
B030SPL1020130Trial, Bi-Convex, Parallel, 26 x 60mm, 12mm
B030SPL1020120Trial, Bi-Convex, Parallel, 26 x 60mm, 10mm
B030SPL1020110Trial, Bi-Convex, Parallel, 26 x 60mm, 8mm
B030SPL1020100Trial, Bi-Convex, Parallel, 22 x 60mm, 16mm
B030SPL1020090Trial, Bi-Convex, Parallel, 22 x 60mm, 14mm
B030SPL1020080Trial, Bi-Convex, Parallel, 22 x 60mm, 12mm
B030SPL1020070Trial, Bi-Convex, Parallel, 22 x 60mm, 10mm
B030SPL1020060Trial, Bi-Convex, Parallel, 22 x 60mm, 8mm
B030SPL1020050Trial, Bi-Convex, Parallel, 18 x 60mm, 16mm
B030SPL1020040Trial, Bi-Convex, Parallel, 18 x 60mm, 14mm
B030SPL1020030Trial, Bi-Convex, Parallel, 18 x 60mm, 12mm
B030SPL1020010Trial, Bi-Convex, Parallel, 18 x 60mm, 8mm
B030SPL1030010Lateral Inserter Handle
B030SPL1020520Trial, Bi-Convex, Parallel, 18 x 60mm, 6mm
B030SPL1020510Trial, Bi-Convex, 20° Lordotic, 26 x 60mm, 16mm
B030SPL1020500Trial, Bi-Convex, 20° Lordotic, 26 x 60mm, 14mm
B030SPL1020490Trial, Bi-Convex, 20° Lordotic, 22 x 60mm, 16mm
B030SPL1020480Trial, Bi-Convex, 20° Lordotic, 22 x 60mm, 14mm
B030SPL1020470Trial, Bi-Convex, 20° Lordotic, 22 x 60mm, 12mm

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