FDA.reportPublic FDA data

NA

Primary DI
10705034719856
Brand
NA
Company
Synthes GmbH
Model
03.632.370
Catalog number
03632370
Device description
NAVIGABLE CANNULATED TAP 7.0MM DUAL CORE/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
07611819588882Direct MarkingGS10
10705034719856PrimaryGS10
H981036323700SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819588882076118195888827611819588882
1070503471985610705034719856

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. 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
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00763000994501Stealth AXiS Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994525Stealth AXiS Advanced Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994549Stealth AXiS EM Emitter Arm Bed Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994563Stealth AXiS EM Spine Retractors Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
006283415208297D Surgical FLASH EVD Procedural Kit7D Surgical ULCHAW2026-04-08
006283415208367D Surgical FLASH EVD Non-Sterile Kit7D Surgical ULCHAW2026-04-08
006283415208437D Surgical FLASH EVD Sterile Kit7D Surgical ULCHAW2026-04-08
00628341521352FLASH EVD System7D Surgical ULCHAW2026-04-08
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00810180350051ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
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006283415213837D Surgical Universal Array (5)7D Surgical ULCOLO2025-07-28
006283415213907D Surgical Universal Array (6)7D Surgical ULCOLO2025-07-28
00850042604311Paradigm Drill Guide TrocarProprio, Inc.OLO2025-06-09
00810180350266ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
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00810180350525ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
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00810180350563ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350693ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00850030914347SkyWalkerMicroport Navibot International LLCOLO2025-04-24
00850030914354SkyWalkerMicroport Navibot International LLCOLO2025-04-24
00850042604014ParadigmProprio, Inc.OLO2025-03-21
00850042604168ParadigmProprio, Inc.OLO2025-03-21