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ReConnex™

FDA UDI

Class II (US FDA UDI)

by Allosource

Identity

Trade Name
ReConnex™ FDA UDI
Generic Name
Tendon graft FDA UDI
Device Name
ReConnex™ Pre-Sutured Tendon FDA UDI
Model / Reference
PST17115 FDA UDI
Description
ReConnex™ Pre-Sutured Tendon FDA UDI

Identifiers

Catalog Number
PST17115 FDA UDI
Primary DI / UDI-DI
M536PST17115 FDA UDI
510(k) Number
K170957 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Tendon graft FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 70 Millimeter FDA UDI
Outer Diameter — 11.5 Millimeter FDA UDI

Category: Tendon graft

ReConnex™ by Allosource — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tendon graft.

Cleared under the same submission

K170957 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Allosource

Sources (1)

  • FDA UDI 8bc7e1f5-5ba4-43f7-95f8-e11aa86b3d5c 37 fields · synced Jun 8, 2026