FDA.reportPublic FDA data

NA

Primary DI
H981046343250
Brand
NA
Company
Synthes GmbH
Model
04.634.325
Catalog number
04634325
Device description
5.5MM TI HARD ROD 125MM
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
K092929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092929000SYNTHES MATRIX SYSTEMSynthes (Usa)2009-12-29NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034747743PrimaryGS10
H981046343250SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503474774310705034747743

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
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14
10886982077899NA03.311.013033110132015-09-14
10886982078131NA03.311.058033110582015-09-14
10886982078148NA03.311.059033110592015-09-14
10886982078155NA03.311.060033110602015-09-14
10886982078186NA03.311.062033110622015-09-14
10886982078193NA03.311.070033110702015-09-14
10886982078209NA03.311.071033110712015-09-14
10886982078247NA03.311.090033110902015-09-14
10886982078254NA03.311.091033110912015-09-14
10886982078261NA03.311.092033110922015-09-14
10886982078438NA03.311.201033112012015-09-14
10886982078445NA03.311.202033112022015-09-14
10886982078452NA03.311.203033112032015-09-14
10886982078469NA03.311.204033112042015-09-14
10886982078476NA03.311.205033112052015-09-14
10886982078520NA03.311.220033112202015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
10889981065348MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065683MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065706MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065720MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065744MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065768MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065782MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065805MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065829MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065843MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065867MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065881MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065904MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065928MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065959MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065966MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065973MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065980MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065997MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981066000MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981066017MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981066024MarinerSeaspine Orthopedics CorporationMNI2016-09-02