FDA.reportPublic FDA data

Thunderbolt

Primary DI
00811714036458
Brand
Thunderbolt
Company
RESPONSIVE ORTHOPEDICS LLC
Model
285957
Catalog number
285957
Device description
Thunderbolt Implant
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203121000Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC2021-04-27MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811714036458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811714036458008117140364588117140364580811714036458

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002745858
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811714035888Shadow Knotless920002-0000-P920002-0000-P2023-11-06
00811714035864Mini Stealth911008-0000-P911008-0000-P2023-10-16
00811714035871Stealth918001-0000-P918001-0000-P2023-10-16
00811714036472Thunderbolt2859592859592026-07-31
00811714036489Thunderbolt2859602859602026-07-31
00811714036533Thunderbolt2859652859652025-05-14
00811714036540Thunderbolt2859662859662025-05-14
00811714036557Thunderbolt2859672859672025-05-14
00811714036564Thunderbolt2859682859682025-05-14
00811714036571Thunderbolt2859692859692025-05-14
00811714036588Thunderbolt2859702859702025-05-14
00811714036595Thunderbolt2859712859712025-05-14
00811714036601Thunderbolt2859722859722025-05-14
00811714036618Thunderbolt2859732859732025-05-14
00811714036403Shadow Mini Instruments2859522859522026-02-03
00811714036427Shadow Knotless Instruments2859542859542026-02-03
00811714036397Shadow Mini All-Suture Anchor2859512859512025-05-14
00811714036380Shadow Instruments2859502859502025-12-31
00811714036373Shadow All-Suture Anchor2859492859492025-05-14
00811714036625Mini Superhawk Suture Anchor2859802859802025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815432026241HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
00815432026258HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
00815432027255DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-06-03
00815432026111DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026128DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026135HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026142HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026180HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026197HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026203HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026326DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026340HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432027279DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432027286DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432027521DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2019-12-11
00815432027538DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2019-12-11
00815432027545DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2019-12-11
00815432027552DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2019-12-11
10886705030897HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030903HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030910HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030927HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030934HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030941HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
00815432026531MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2019-03-04
00815432026548MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2019-03-04
00815432026555MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2019-03-04
00815432026562MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2019-03-04
00815432026579MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2019-03-04
00815432026586MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2019-03-04