FDA.reportPublic FDA data

GII

Primary DI
07640173166108
Brand
GII
Company
coLigne AG
Model
83.835
Device description
flexStaas poly axial screw
Published
2021-07-01
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210306000GII Spinal Fixation SystemColigne AG2021-05-19NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640173166108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640173166108076401731661087640173166108

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41433438000info@coligne.com

Regulatory Flags#

DUNS number
482467792
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640173165170GII83.5302021-07-01
07640173165187GII83.5352021-07-01
07640173165194GII83.5402021-07-01
07640173165200GII83.5452021-07-01
07640173165217GII83.5502021-07-01
07640173165224GII83.5552021-07-01
07640173165231GII83.6302021-07-01
07640173165248GII83.6352021-07-01
07640173165255GII83.6402021-07-01
07640173165262GII83.6452021-07-01
07640173165279GII83.6502021-07-01
07640173165286GII83.6552021-07-01
07640173165293GII83.6602021-07-01
07640173165309GII83.7352021-07-01
07640173165316GII83.7402021-07-01
07640173165323GII83.7452021-07-01
07640173165330GII83.7502021-07-01
07640173165347GII83.7552021-07-01
07640173165354GII83.7602021-07-01
07640173165361GII83.7702021-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157113384ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113391ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113407ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113414ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113421ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113438ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113445ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113452ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113469ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113476ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113483ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113490ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113506ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113513ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113520ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113537ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113544ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113551ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113568ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113575ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113582ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113599ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113605ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113612ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113629ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113636ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113643ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113650ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113667ZAVATION SCREWZavation LLCNKB2026-09-04
00197157113674ZAVATION SCREWZavation LLCNKB2026-09-04