FDA.reportPublic FDA data

GMA 2.0 Pedicle Screw System

Primary DI
00810021380209
Brand
GMA 2.0 Pedicle Screw System
Company
GRAFTON MEDICAL ALLIANCE, INC.
Model
101-0030-N
Catalog number
101-0030-N
Device description
PRE-BENT ROD, ø5.5 X 30
Published
2019-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K133063000
K192915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133063000SANTIS PEDICLE SCREW SYSTEMLanterna Medical Technologies2014-01-13NKB
K192915000GMA 2.0 Pedicle Screw SystemGrafton Medical Alliance2019-11-13NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021380209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021380209008100213802098100213802090810021380209

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
630-568-3061bsanchez@gmasurgical.com

Regulatory Flags#

DUNS number
063381119
Device count
1
Lot or batch
true
Manufacturing date on label
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
00810021380216GMA 2.0 Pedicle Screw System101-0035-N101-0035-N2019-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
06009699901715Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
00810088650970Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651052Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651144Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651151Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651168Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651175Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651182Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651366Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651373Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651380Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651397Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651403Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651588Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651595Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651601Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651618Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651632Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651816Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651823Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12