FDA.reportPublic FDA data

NA

Primary DI
10705034719641
Brand
NA
Company
Synthes GmbH
Model
03.632.234
Catalog number
03632234
Device description
NAVIGABLE CANNULATED 3.5MM HEX SCREWDRIVER SHAFT-6MM HXC
Published
2016-06-30
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
HAWNeurological stereotaxic Instrument
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122211000SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSSynthes Spine2012-12-17HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819588707Direct MarkingGS10
10705034719641PrimaryGS10
H981036322340SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819588707076118195887077611819588707
1070503471964110705034719641

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
10887587078540NASD03.501.442SD035014422026-07-29
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425696RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425702RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425719RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425726RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
G076A900687A0Localite TMS Navigator TSLOCALITE GmbHHAW2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOLO2026-08-03
00840606195546Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195553Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195560Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195577Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195584Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195591Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195607Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195614Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195621Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195638Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30