FDA.reportPublic FDA data

QuickGraft

Primary DI
W41844300PSTT165
Brand
QuickGraft
Company
Musculoskeletal Transplant Foundation, Inc.
Model
430PST
Catalog number
430PST
Device description
QuickGraft Pre-Sutured Tendon
Published
2019-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GATSuture, Nonabsorbable, Synthetic, Polyethylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181633000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181633000MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation2019-03-15GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
W41844300PSTT165PrimaryICCBBA0

GMDN Terms#

Term, Definition table
TermDefinition
Tendon graftA sterile tendon tissue, which may include a bone block, intended for transplantation that is harvested from a human donor. The tissue is intended to be used to replace or strengthen damaged tendon in any part of the human body. It may include non-tissue components (e.g. suture) to facilitate its implantation or function. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-90 Degrees Celsius-40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-433-6576RA_Licenses@mtf.org

Regulatory Flags#

DUNS number
187560545
Device count
1
HCT/P
true
Serial number
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
W4184420810T0473Legacy DBM4208104208102022-07-01
W4184420800T0473Legacy DBM4208004208002022-07-01
W4184420801T0473Legacy DBM4208014208012022-07-01
W4184420802T0473Legacy DBM4208024208022022-07-01
W4184420805T0473Legacy DBM4208054208052022-07-01
00859070006005Cascade9100469100462016-12-01
00859070006012Cascade9100449100442016-12-01
00859070006029Cascade9100479100472016-12-01
00859070006036Cascade9100509100502016-12-01
00859070006043Cascade9100489100482016-12-01
W4184227007T0473DBX2270072270072019-06-24
W4184048150T0479DBX®0481500481502016-02-19
W4184048010T0479DBX®0480100480102016-02-19
W4184048015T0479DBX®0480150480152016-02-19
W4184048025T0479DBX®0480250480252016-02-19
W4184048050T0479DBX®0480500480502016-02-19
W4184048125T0479DBX®0481250481252016-02-19
00859070006050LipoGrafter9130002018-09-21
W4184030005T0473DBX®0300050300052016-02-19
W4184030010T0473DBX®0300100300102016-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHGAT2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHGAT2024-04-12
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHGAT2024-02-06
07649990202020Tray_SF Push-In Anchor 2.3Surgical Fusion Technologies GmbHGAT2024-01-10
07649990202181Handpiece Front CoverSurgical Fusion Technologies GmbHGAT2024-01-10
07649990202013Tray_SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202037Sonotrode PI-S 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202044Twist Drill PI-C 1.8Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202051Wrench 5.0Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202150BoneWelder 150-W1Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202167SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-08
10652927144151DemeBONDDemetech CorporationGAT2019-07-16
10652927144168DemeBONDDemetech CorporationGAT2019-07-16
10652927150312DemeBONDDemetech CorporationGAT2019-07-16
10652927158936DemeBONDDemetech CorporationGAT2019-07-16
10652927158943DemeBONDDemetech CorporationGAT2019-07-16
10652927158950DemeBONDDemetech CorporationGAT2019-07-16
10652927158967DemeBONDDemetech CorporationGAT2019-07-16
10652927158974DemeBONDDemetech CorporationGAT2019-07-16
10652927160878DemeBONDDemetech CorporationGAT2019-07-16
10652927160885DemeBONDDemetech CorporationGAT2019-07-16
10652927161134DemeBONDDemetech CorporationGAT2019-07-16
10652927161141DemeBONDDemetech CorporationGAT2019-07-16
10652927164562DemeBONDDemetech CorporationGAT2019-07-16