FDA.reportPublic FDA data

GMA 2.0 Pedicle Screw System

Primary DI
00810021380469
Brand
GMA 2.0 Pedicle Screw System
Company
GRAFTON MEDICAL ALLIANCE, INC.
Model
PSS-IMPTRAY-00
Catalog number
PSS-IMPTRAY-00
Device description
IMPLANT TRAY
Published
2020-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192915000GMA 2.0 Pedicle Screw SystemGrafton Medical Alliance2019-11-13NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021380469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021380469008100213804698100213804690810021380469

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6305683066bsanchez@gmasurgical.com

Regulatory Flags#

DUNS number
063381119
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810021380018GMA 2.0 Pedicle Screw System601-5530-D601-5530-D2019-04-25
00810021380025GMA 2.0 Pedicle Screw System601-5535-D601-5535-D2019-04-25
00810021380032GMA 2.0 Pedicle Screw System601-5540-D601-5540-D2019-04-25
00810021380049GMA 2.0 Pedicle Screw System601-5545-D601-5545-D2019-04-25
00810021380056GMA 2.0 Pedicle Screw System601-5550-D601-5550-D2019-04-25
00810021380063GMA 2.0 Pedicle Screw System601-5555-D601-5555-D2019-04-25
00810021380070GMA 2.0 Pedicle Screw System601-6535-D601-6535-D2019-04-25
00810021380087GMA 2.0 Pedicle Screw System601-6540-D601-6540-D2019-04-25
00810021380094GMA 2.0 Pedicle Screw System601-6545-D601-6545-D2019-04-25
00810021380100GMA 2.0 Pedicle Screw System601-6550-D601-6550-D2019-04-25
00810021380117GMA 2.0 Pedicle Screw System601-6555-D601-6555-D2019-04-25
00810021380124GMA 2.0 Pedicle Screw System601-6560-D601-6560-D2019-04-25
00810021380131GMA 2.0 Pedicle Screw System601-7535-D601-7535-D2019-04-25
00810021380148GMA 2.0 Pedicle Screw System601-7540-D601-7540-D2019-04-25
00810021380155GMA 2.0 Pedicle Screw System601-7545-D601-7545-D2019-04-25
00810021380162GMA 2.0 Pedicle Screw System601-7550-D601-7550-D2019-04-25
00810021380179GMA 2.0 Pedicle Screw System601-7555-D601-7555-D2019-04-25
00810021380186GMA 2.0 Pedicle Screw System601-7560-D601-7560-D2019-04-25
00810021380193GMA 2.0 Pedicle Screw System005-5670005-56702019-04-25
00810021380209GMA 2.0 Pedicle Screw System101-0030-N101-0030-N2019-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
03700780634583Erisma®-LPCLARIANCEMNH2026-05-28
03700780634583Erisma®-LPCLARIANCEMNI2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28