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Cervical Plate 100089-57

by Eisertech, LLC

Cervical Plate 100089-57 is an orthopaedic fixation plate (FDA Class II; FDA product code KWQ, Appliance, Fixation, Spinal Intervertebral Body) made by Eisertech, LLC, cleared under FDA 510(k) K113170 on 6 Apr 2012 and listed in FDA GUDID since 7 Apr 2017 (UDI-DI B52310008957), 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) K113170

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 NumberB52310008957 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113170 Date6 Apr 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113170 decided 6 Apr 2012 Active
  • FDA GUDID UDI-DI B52310008957 listed 7 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113170
  2. Listed FDA GUDID B52310008957

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cervical Plate
Generic name
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Model / Ref / Catalog
100089-57
Description
Cervical Plate - 3 Level x 57mm
Primary DI / UDI-DI
B52310008957
510(k) Number
FDA product code
KWQ
GMDN term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Cleared under the same submission (K113170)

and 8 more cleared under K113170

Similar devices in this category

Other devices filed under Orthopaedic fixation plate, non-bioabsorbable, non-sterile.

Other devices from Eisertech, LLC

See all devices from Eisertech, LLC →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)