FDA.reportPublic FDA data

NA

Primary DI
H981046517100
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
04.651.710
Catalog number
04651710
Device description
5.5MM TI MIN INVASIVE STRAIGHT ROD 310MM
Published
2015-09-14
Public version status
Update
Distribution status
Not 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
K113044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113044000SYNTHES MIRSSynthes Spine2011-12-21NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034752204PrimaryGS10
H981046517100SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503475220410705034752204

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
832637081
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
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2015-08-05
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04546540147769XIA IIStryker CorporationMNH2014-12-08
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04546540147905XIA IIStryker CorporationMNH2014-12-08
04546540147912XIA IStryker CorporationMNH2014-12-08
04546540147929XIA IStryker CorporationMNH2014-12-08
04546540147936XIA IStryker CorporationMNH2014-12-08
04546540147974XIA IStryker CorporationMNH2014-12-08
04546540147981XIA IStryker CorporationMNH2014-12-08
04546540147998XIA IStryker CorporationMNH2014-12-08
04546540148001XIA IIStryker CorporationMNH2014-12-08
04546540148018XIA IIStryker CorporationMNH2014-12-08
04546540148025XIA IIStryker CorporationMNH2014-12-08
04546540148735XIA IIStryker CorporationMNH2014-12-08
04546540148742XIA IIStryker CorporationMNH2014-12-08
04546540148759XIA IIStryker CorporationMNH2014-12-08
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04546540148773XIA IIStryker CorporationMNH2014-12-08
04546540148780XIA IIStryker CorporationMNH2014-12-08
04546540148797XIA IIStryker CorporationMNH2014-12-08
04546540148803XIA IIStryker CorporationMNH2014-12-08
04546540148810XIA IIStryker CorporationMNH2014-12-08
04546540148827XIA IIStryker CorporationMNH2014-12-08
04546540148834XIA IIStryker CorporationMNH2014-12-08
04546540148841XIA IIStryker CorporationMNH2014-12-08