FDA.reportPublic FDA data

NA

Primary DI
10705034751450
Brand
NA
Company
Synthes GmbH
Model
04.647.878S
Catalog number
04647878S
Device description
3.7MM TI CERV SPN SCR SLF-TPNG VARIABLE ANGLE 18MM-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
10705034751450PrimaryGS10
H98104647878S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503475145010705034751450

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
10886982198266NA391.73391732016-12-31
10886982312259NA60.133.200601332002022-04-12
10886982312266NA60.133.300601333002022-06-17
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913657Saber-C Body (PT), 12x15x6 6 deg.ELEVATION SPINE, INC.OVE2026-06-01
M711511410070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511410120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511411070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511411120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511412070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511412120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511606070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511607070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511607120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511608070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511608120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511609070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511609120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511610070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511610120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511611070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511611120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511612070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511612120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511806070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511807070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511807120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511808070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511808120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511809070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511809120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511810070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511810120Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31
M711511811070Endeavor™ Stand-Alone CervicalINNO Holdings, Inc.OVE2026-05-31