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Excella 3® E35555

by INNO Holdings, Inc.

Excella 3® E35555 is a Class II device made by INNO Holdings, Inc., cleared under FDA 510(k) K102248 on 7 Oct 2010 and listed in FDA GUDID since 5 Jul 2019 (UDI-DI M711E355550), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K102248

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 NumberM711E355550 UDI-DI Date5 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK102248 Date7 Oct 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102248 decided 7 Oct 2010 Active
  • FDA GUDID UDI-DI M711E355550 listed 5 Jul 2019 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0644-2018 FDA Class II initiated 8 Jan 2018

    Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

    • Terminated Z-0662-2016 FDA Class II initiated 7 Dec 2015

    Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.

    • Terminated Z-2067-2014 FDA Class II initiated 7 Jul 2014

    Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

Timeline

5 dated events

  1. Cleared FDA 510(k) K102248
  2. Recall initiated FDA recalls Z-2067-2014
  3. Recall initiated FDA recalls Z-0662-2016
  4. Recall initiated FDA recalls Z-0644-2018
  5. Listed FDA GUDID M711E355550

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Excella 3®
Generic name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
E35555
Primary DI / UDI-DI
M711E355550
FDA product code
NKB, MNI, MNH, KWP, KWQ
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3070, 888.3050, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5.5 Millimeter
Length — 55 Millimeter

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K102248)

and 8 more cleared under K102248

Other devices from INNO Holdings, Inc.

See all devices from INNO Holdings, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)