Spira-A

GUDID B030CG1080100

Curette #0, Straight, 17", 8" Silicone Handle, DLC Coating

CAMBER SPINE TECHNOLOGIES, LLC

Bone curette, reusable
Primary Device IDB030CG1080100
NIH Device Record Keyc63b96a2-32c3-4633-9f77-2480321c926a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpira-A
Version Model NumberCG-108-010
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 Batchfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030CG1080100 [Primary]

FDA Product Code

HTFCurette

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030CG1080100]

Moist Heat or Steam Sterilization


[B030CG1080100]

Moist Heat or Steam Sterilization


[B030CG1080100]

Moist Heat or Steam Sterilization


[B030CG1080100]

Moist Heat or Steam Sterilization


[B030CG1080100]

Moist Heat or Steam Sterilization


[B030CG1080100]

Moist Heat or Steam Sterilization


[B030CG1080100]

Moist Heat or Steam Sterilization


[B030CG1080100]

Moist Heat or Steam Sterilization


[B030CG1080100]

Moist Heat or Steam Sterilization


[B030CG1080100]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-27
Device Publish Date2025-02-19

On-Brand Devices [Spira-A]

B030SPA504080Implant Caddy Assembly
B030SPA504070Implant Caddy Assembly
B030SPA504060Implant Caddy Assembly
B030SPA504050Implant Caddy Assembly
B030SPA504040Implant Caddy Assembly
B030SPA504030Implant Caddy Assembly
B030SPA504020Implant Caddy Assembly
B030SPA504010Implant Caddy Assembly
B030SPA502110Trial Caddy Assembly
B030SPA502100Trial Caddy Assembly
B030SPA502090Trial Caddy Assembly
B030SPA500002020Bottom Layer
B030SPA500002010Top Layer
B030SPA5000020Instrument Tray Assembly, SPIRA Open Matrix ALIF
B030SPA500001030Bottom Layer
B030SPA500001020Middle Tray
B030SPA500001010Top Tray
B030SPA5000010Implant Case Assembly, SPIRA Open Matrix ALIF
B030SPA102302060° Trial, Bi-Convex 15° Lordotic, 47mm x 18mm, 13mm
B030SPA102206060° Trial, Bi-Convex 20° Lordotic, 29mm x 18mm, 15mm
B030SPA102205060° Trial, Bi-Convex 20° Lordotic, 37mm x 18mm, 15mm
B030SPA102204060° Trial, Bi-Convex 20° Lordotic, 37mm x 18mm, 13mm
B030SPA102203060° Trial, Bi-Convex 15° Lordotic, 37mm x 18mm, 15mm
B030SPA102202060° Trial, Bi-Convex 15° Lordotic, 37mm x 18mm, 13mm
B030SPA102201060° Trial, Bi-Convex 15° Lordotic, 29mm x 18mm, 13mm
B030SPA102108060° Trial, Bi-Convex 20° Lordotic, 26mm x 32mm, 15mm
B030SPA102106060° Trial, Bi-Convex 20° Lordotic, 30mm x 38mm, 15mm
B030SPA102105060° Trial, Bi-Convex 20° Lordotic, 30mm x 38mm, 13mm
B030SPA102104060° Trial, Bi-Convex 15° Lordotic, 30mm x 38mm, 15mm
B030SPA102103060° Trial, Bi-Convex 15° Lordotic, 30mm x 38mm, 13mm
B030SPA102101060° Trial, Bi-Convex 15° Lordotic, 26mm x 32mm, 13mm
B030SPA1020410Trial, 30 x 38mm, 20° Lordotic, 19mm
B030SPA1020400Trial, 30 x 38mm, 20° Lordotic, 17mm
B030SPA1020390Trial, 30 x 38mm, 20° Lordotic, 15mm
B030SPA1020380Trial, 30 x 38mm, 20° Lordotic, 13mm
B030SPA1020350Trial, 30 x 38mm, 15° Lordotic, 19mm
B030SPA1020340Trial, 30 x 38mm, 15° Lordotic, 17mm
B030SPA1020330Trial, 30 x 38mm, 15° Lordotic, 15mm
B030SPA1020320Trial, 30 x 38mm, 15° Lordotic, 13mm
B030SPA1020310Trial, 30 x 38mm, 15° Lordotic, 11mm
B030SPA1020290Trial, 30 x 38mm, 8° Lordotic, 19mm
B030SPA1020280Trial, 30 x 38mm, 8° Lordotic, 17mm
B030SPA1020270Trial, 30 x 38mm, 8° Lordotic, 15mm
B030SPA1020260Trial, 30 x 38mm, 8° Lordotic, 13mm
B030SPA1020250Trial, 30 x 38mm, 8° Lordotic, 11mm
B030SPA1020240Trial, 30 x 38mm, 8° Lordotic, 9mm
B030SPA1020230Trial, 26 x 32mm, 20° Lordotic, 17mm
B030SPA1020220Trial, 26 x 32mm, 20° Lordotic, 15mm
B030SPA1020210Trial, 26 x 32mm, 20° Lordotic, 13mm
B030SPA1020200Trial, 26 x 32mm, 20° Lordotic, 11mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.