FDA.reportPublic FDA data

NA

Primary DI
H981046512800
Brand
NA
Company
Synthes GmbH
Model
04.651.280
Catalog number
04651280
Device description
5.5MM TI MIN INVASIVE CURVED ROD 200MM RADIUS/80MM
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093668000SYNTHES MATRIX MIS RODSSynthes (Usa)2010-03-09NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034751719PrimaryGS10
H981046512800SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503475171910705034751719

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
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationMNH2026-07-24
07290115932508Tower Guide STPREMIA SPINE LTDMNH2026-07-23
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
04047844129418DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129425DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129555DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129562DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129579DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129586DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129593DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129609DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129616DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129623DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129630DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13