FDA.reportPublic FDA data

TIGER18

Primary DI
03701091000524
Brand
TIGER18
Company
ADSM
Model
HV1815
Catalog number
HV1815
Device description
Snap-off threaded pin
Published
2020-12-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K151241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151241000Synchro-Medical TIGER TRACK Screw SystemSynchro Medical2015-08-07HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701091000524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701091000524037010910005243701091000524

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Millimeter
Outer Diameter1.8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33428710310office@synchromedical.com
+1 409-658-1017info@iotiot.com

Regulatory Flags#

DUNS number
266749350
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701091006250PURIST 6813009B6813009B2023-04-24
03701091006267PURIST 6813040B6813040B2023-04-24
03701091006274PURIST 6813049B6813049B2023-04-24
03701091006281PURIST 6883314B6883314B2023-04-24
03701091006298PURIST 6883360B6883360B2023-04-24
03701091006304PURIST6813037B6813037B2023-04-24
03701091006311PURIST6813123B6813123B2023-04-24
03701091006328PURIST 6813035B6813035B2023-04-24
03701091006335PURIST 6813041B6813041B2023-04-24
03701091006342PURIST 6813048B6813048B2023-04-24
03701091005369PURIST 688331468833142022-11-28
03701091005376PURIST 688336068833602022-11-28
03701091005383PURIST 681311768131172022-11-28
03701091005390PURIST 681311868131182022-11-28
03701091005406PURIST 681311968131192022-11-28
03701091005413PURIST681311468131142022-11-28
03701091005420PURIST 681312068131202022-11-28
03701091005437PURIST 681311668131162022-11-28
03701091005444PURIST 681300268130022022-11-28
03701091005451PURIST 681300968130092022-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01