FDA.reportPublic FDA data

ReConnex™

Primary DI
M536PST17080
Brand
ReConnex™
Company
ALLOSOURCE
Model
PST17080
Catalog number
PST17080
Device description
ReConnex™ Pre-Sutured Tendon
Published
2018-08-15
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
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
M536PST17080PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter
Outer Diameter8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-40 Degrees Celsius

Regulatory Flags#

DUNS number
946808136
Device count
1
HCT/P
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
M536PST17070ReConnex™PST17070PST170702018-08-15
M536PST17075ReConnex™PST17075PST170752018-08-15
M536PST17085ReConnex™PST17085PST170852018-08-15
M536PST17090ReConnex™PST17090PST170902018-08-15
M536PST17095ReConnex™PST17095PST170952018-08-15
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
M536900380011AlloFuse® 90038001900380012015-09-24
M536900380021AlloFuse®90038002900380022015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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