FDA.reportPublic FDA data

MINI

Primary DI
07613327363289
Brand
MINI
Company
Stryker GmbH
Model
IS1101
Catalog number
IS1101
Device description
Fixed Driver Handle
Published
2017-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120493000MINI CANNULATED HEADED AND HEADLESS SCREW SETInstratek, Inc.2012-05-17HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327363289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327363289076133273632897613327363289

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

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327616859HOFFMANN LRF4936-0-1304936-0-1302026-07-23
07613327616880HOFFMANN LRF4936-1-3054936-1-3052026-07-23
07613327649109T2, PANGEA5431405431402025-09-25
07613327649130T2, PANGEA5431705431702025-09-25
07613327649253T2, PANGEA6497-1-0606497-1-0602025-09-25
07613327649260T2, PANGEA6497-1-0706497-1-0702025-09-25
07613327649277T2, PANGEA6497-1-070S6497-1-070S2025-09-25
07613327649284T2, PANGEA6497-1-060S6497-1-060S2025-09-25
07613327649291T2, PANGEA6497-1-0806497-1-0802025-09-25
07613327649307T2, PANGEA6497-1-0906497-1-0902025-09-25
07613327649314T2, PANGEA6497-1-080S6497-1-080S2025-09-25
07613327649321T2, PANGEA6497-1-090S6497-1-090S2025-09-25
07613327649338T2, PANGEA6497-1-1006497-1-1002025-09-25
07613327649345T2, PANGEA6497-1-1106497-1-1102025-09-25
07613327649352T2, PANGEA6497-1-100S6497-1-100S2025-09-25
07613327649369T2, PANGEA6497-1-110S6497-1-110S2025-09-25
07613327649376T2, PANGEA6497-1-1306497-1-1302025-09-25
07613327649383T2, PANGEA6497-1-130S6497-1-130S2025-09-25
07613327649390T2, PANGEA6497-1-120S6497-1-120S2025-09-25
07613327649406T2, PANGEA6497-1-1206497-1-1202025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449002511LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002528LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002535LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002542LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002559LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002566LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002573LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002580LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002597LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002603LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002610LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002627LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002634LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002641LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002658LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002665LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002672LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002689LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002696LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002702LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002719LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002726LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002733LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002740LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002757LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002764LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002771LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002788LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002795LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002801LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08