FDA.reportPublic FDA data

ReConnex™

Primary DI
M536PST17095
Brand
ReConnex™
Company
ALLOSOURCE
Model
PST17095
Catalog number
PST17095
Device description
ReConnex™ Pre-Sutured Tendon
Published
2018-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
K170957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170957000ReConnex Pre-Sutured TendonAllosource2018-03-20GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M536PST17095PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tendon graftProcessed (e.g., sterilised, aseptically processed) tendon tissue, harvested from a human donor, which may include a bone block, intended for transplantation to replace or strengthen damaged tendon. It may include non-tissue components (e.g. suture) to facilitate its implantation or function. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
946808136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M536PST17070ReConnex™PST17070PST170702018-08-15
M536PST17075ReConnex™PST17075PST170752018-08-15
M536PST17080ReConnex™PST17080PST170802018-08-15
M536PST17085ReConnex™PST17085PST170852018-08-15
M536PST17090ReConnex™PST17090PST170902018-08-15
M536PST17100ReConnex™PST17100PST171002018-08-15
M536PST17105ReConnex™PST17105PST171052018-08-15
M536PST17110ReConnex™PST17110PST171102018-08-15
M536PST17115ReConnex™PST17115PST171152018-08-15
M536PST17120ReConnex™PST17120PST171202018-08-15
M536PST17125ReConnex™PST17125PST171252018-08-15
M536PST17130ReConnex™PST17130PST171302018-08-15
00810053078655AceConnex™PSF141060-5PSF141060-52023-11-08
00810053078662AceConnex™PSF141060-6PSF141060-62023-11-08
00810053078679AceConnex™PSF141100-5PSF141100-52023-11-08
00810053078686AceConnex™PSF141100-6PSF141100-62023-11-08
00810053078693AceConnex™PSF141140-5PSF141140-52023-11-08
00810053078709AceConnex™PSF141140-6PSF141140-62023-11-08
M536900380011AlloFuse® 90038001900380012015-09-24
M536900380021AlloFuse®90038002900380022015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031097414MERSILENEETHICON, LLCGAT2026-08-17
00860424000273SpeedGraft QuadLink TendonJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000280PilotGraft BTB Tendon, 9 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00860424000297PilotGraft BTB Tendon, 11 mmJOINT RESTORATION FOUNDATION INCGAT2024-07-15
00191083047676RapidEase™Rti Surgical, Inc.GAT2023-11-03
00191083047683RapidEase™Rti Surgical, Inc.GAT2023-11-03
00860424000266SpeedGraft Achilles TendonJOINT RESTORATION FOUNDATION INCGAT2022-08-31
00860424000259JRF PilotGraft BTBJOINT RESTORATION FOUNDATION INCGAT2021-04-02
00860424000242JRF VersaGraft 3.5JOINT RESTORATION FOUNDATION INCGAT2018-09-18
14026704426260DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
14026704427250DEKNATELTELEFLEX INCORPORATEDGAT2017-04-19
00860424000235JRF GraftLink XLJOINT RESTORATION FOUNDATION INCGAT2016-03-30
00889858118491FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117111FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117135FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117159FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117173FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117210FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117234FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117258FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117296FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117333FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117357FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117371FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117432FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117456FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117494FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117517FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117555FlexiGRAFT®LIFENET HEALTHGAT2015-09-24
00889858117579FlexiGRAFT®LIFENET HEALTHGAT2015-09-24