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ReConnex™ PST17115

by Allosource

ReConnex™ PST17115 is a Class II device made by Allosource, cleared under FDA 510(k) K170957 on 20 Mar 2018 and listed in FDA GUDID since 15 Aug 2018 (UDI-DI M536PST17115), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K170957

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM536PST17115 UDI-DI Date15 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170957 Date20 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170957 decided 20 Mar 2018 Active
  • FDA GUDID UDI-DI M536PST17115 listed 15 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170957
  2. Listed FDA GUDID M536PST17115

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ReConnex™
Generic name
Tendon graft
Model / Ref / Catalog
PST17115
Primary DI / UDI-DI
M536PST17115
510(k) Number
FDA product code
GAT
GMDN term
Tendon graft
Device class
Class II
Regulation number
878.5000
GUDID distribution status
In Commercial Distribution
Size
Length — 70 Millimeter
Outer Diameter — 11.5 Millimeter

Related devices

Category: Tendon graft

Cleared under the same submission (K170957)

and 8 more cleared under K170957

Similar devices

Also classified as Tendon graft.

Similar devices

Other devices filed under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Other devices from Allosource

See all devices from Allosource →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • HCT/P
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (7, all answered No)