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PLIF Cage 100035-280910

by Eisertech, LLC

PLIF Cage 100035-280910 is a Class II device made by Eisertech, LLC, cleared under FDA 510(k) K113478 on 5 Mar 2012 and listed in FDA GUDID since 11 Apr 2018 (UDI-DI B523100035280910), 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) K113478

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 NumberB523100035280910 UDI-DI Date11 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK113478 Date5 Mar 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113478 decided 5 Mar 2012 Active
  • FDA GUDID UDI-DI B523100035280910 listed 11 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113478
  2. Listed FDA GUDID B523100035280910

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PLIF Cage
Generic name
Polymeric spinal interbody fusion cage
Model / Ref / Catalog
100035-280910
Primary DI / UDI-DI
B523100035280910
510(k) Number
FDA product code
MAX
GMDN term
Polymeric spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K113478)

and 8 more cleared under K113478

Similar devices

Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Other devices from Eisertech, LLC

See all devices from Eisertech, LLC →

Properties

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