FDA.reportPublic FDA data

NA

Primary DI
10705034702049
Brand
NA
Company
Synthes GmbH
Model
SD03.617.993
Catalog number
SD03617993
Device description
2.0MM ANGLED AWL BEVEL TIP
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K112068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112068000SYNTHES ZERO-P VARIABLE ANGLE (VA)Synthes Spine Co.Lp2011-11-07OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034702049PrimaryGS10
H981SD036179930SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503470204910705034702049

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982342508VOLT02.535.724025357242026-09-25
10886982342515VOLT02.535.726025357262026-09-25
10886982342522VOLT02.535.728025357282026-09-25
10886982342539VOLT02.535.730025357302026-09-25
10886982342546VOLT02.535.732025357322026-09-25
10886982342553VOLT02.535.734025357342026-09-25
10886982342560VOLT02.535.736025357362026-09-25
10886982342577VOLT02.535.738025357382026-09-25
10886982342584VOLT02.535.740025357402026-09-25
10886982342591VOLT02.535.742025357422026-09-25
10886982342607VOLT02.535.744025357442026-09-25
10886982342614VOLT02.535.746025357462026-09-25
10886982342621VOLT02.535.748025357482026-09-25
10886982342638VOLT02.535.750025357502026-09-25
10886982342645VOLT02.535.752025357522026-09-25
10886982342652VOLT02.535.754025357542026-09-25
10886982342669VOLT02.535.756025357562026-09-25
10886982342676VOLT02.535.758025357582026-09-25
10886982342683VOLT02.535.760025357602026-09-25
10886982344878VOLT02.535.765025357652026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
10888857026551CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
10888857026582CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
07613327506518Anchor CStryker CorporationOVE2019-12-18
10888857027534CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027541CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027558CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027572CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027589CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027596CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027756CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027763CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027770CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027794CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027800CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027817CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027978CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
04546540679147AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679154AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679161AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679178AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679185AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679192AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679208AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711599AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711605AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711612AVS Anchor-CStryker CorporationOVE2016-09-24