FDA.reportPublic FDA data

Tiger

Primary DI
00812926029573
Brand
Tiger
Company
Trilliant Surgical, LLC
Model
200-45-002
Device description
4.5mm Spiked Washer
Published
2019-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone
NDGWasher, Bolt, Nut, Non-Spinal, Metallic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
NDGWasher, Bolt, Nut, Non-Spinal, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153338000Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.2016-01-14HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926029573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926029573008129260295738129260295730812926029573

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028391925Arsenal Foot307-27-0422022-05-02
00810028391932Arsenal Foot307-27-0442022-05-02
00810028391949Arsenal Foot307-27-0462022-05-02
00810028391956Arsenal Foot307-27-0482022-05-02
00810028391963Arsenal Foot307-27-0502022-05-02
00810028391970Arsenal Foot307-35-0552022-05-02
00810028391987Arsenal Foot307-35-0602022-05-02
00810028391994Arsenal Foot307-35-0652022-05-02
00810028392007Arsenal Foot307-35-0702022-05-02
00810028392014Arsenal Foot308-27-0422022-05-02
00810028392021Arsenal Foot308-27-0442022-05-02
00810028392038Arsenal Foot308-27-0462022-05-02
00810028392045Arsenal Foot308-27-0482022-05-02
00810028392052Arsenal Foot308-27-0502022-05-02
00810028392069Arsenal Foot308-35-0552022-05-02
00810028392076Arsenal Foot308-35-0602022-05-02
00810028392083Arsenal Foot308-35-0652022-05-02
00810028392090Arsenal Foot308-35-0702022-05-02
00810028392106Arsenal Foot303-90-0012022-05-02
00810028392113Arsenal Foot303-90-0022022-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053782783830TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783847TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783915TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783922TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783939TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783946TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783953TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783960TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783977TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784134TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784141TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784158TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784165TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784172TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784189TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784264CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784271CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784288CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784295CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784301CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784318CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784325CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784523CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784530CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784547CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784554CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784561CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784578CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784585CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784592CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19