FDA.reportPublic FDA data

NA

Primary DI
10705034751375
Brand
NA
Company
Synthes GmbH
Model
04.647.836S
Catalog number
04647836S
Device description
3.7MM TI CERV SPN SCR SLF-DRLG VARIABLE ANGLE 16MM-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121852000SYNTHES ZERO-P VARIABLE ANGLE (VA)Synthes Spine Co.Lp2012-07-25OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034751375PrimaryGS10
H98104647836S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503475137510705034751375

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
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
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810216329235ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329242ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329259ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329266ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329273ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329280ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329297ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329303ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329310ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329334ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329341ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329358ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329372ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329389ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329396ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329402ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00810216329419ZSAlign Cervical Interbody System-ScrewZsfab, Inc.OVE2026-10-14
00889981124390Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124406Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124413Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124420Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124437Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124444Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124451Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981124468Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142301Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142318Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142325Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142332Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26
00889981142349Shoreline™ ACSSeaspine Orthopedics CorporationOVE2019-07-26