ReConnex™ PST17105
by Allosource
ReConnex™ PST17105 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 M536PST17105), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM536PST17105 | Date15 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170957 | Date20 Mar 2018 | StatusActive |
Official records
- FDA 510(k) database K170957
Across registries
- FDA 510(k) K170957 decided 20 Mar 2018 Active
- FDA GUDID UDI-DI M536PST17105 listed 15 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K170957
- Listed FDA GUDID M536PST17105
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ReConnex™
- Generic name
- Tendon graft
- Model / Ref / Catalog
- PST17105
- Primary DI / UDI-DI
- M536PST17105
- 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 MillimeterOuter Diameter — 10.5 Millimeter
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