FDA.reportPublic FDA data

NA

Primary DI
H981046330010
Brand
NA
Company
Synthes GmbH
Model
04.633.001
Catalog number
04633001
Device description
TI EXTENSION CONNECTOR 5.5MM/5.5MM
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
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113149000SYNTHES USS CONNECTORSSynthes Spine2012-02-01MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034746043PrimaryGS10
H981046330010SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503474604310705034746043

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
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
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04047844129418DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129425DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129555DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129562DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129579DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129586DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129593DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129609DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129616DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129623DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129630DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129647DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129654DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129661DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129678DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129685DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129692DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129708DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13