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Saiph 193-717

by Matortho

Saiph 193-717 is a Class II device made by Matortho, cleared under FDA 510(k) K140222 on 17 Nov 2014 and listed in FDA GUDID since 11 May 2015 (UDI-DI 05055455506381), active as of 22 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 22 Oct 2026

Documents

510(k) K140222

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055455506381 UDI-DI Date11 May 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140222 Date17 Nov 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140222 decided 17 Nov 2014 Active
  • FDA GUDID UDI-DI 05055455506381 listed 11 May 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140222
  2. Listed FDA GUDID 05055455506381

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Saiph
Generic name
Tibial insert
Model / Ref / Catalog
193-717
Primary DI / UDI-DI
05055455506381
510(k) Number
FDA product code
JWH
GMDN term
Tibial insert
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Tibial insert.

Other devices from Matortho

  • Saiph® 293-727

    Class II
  • Saiph® 293-731

    Class II
  • Saiph® 290-162

    Class II
  • Saiph® 293-268

    Class II

See all devices from Matortho →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)