Cervical Plate 100065-0

by Eisertech, LLC

Cervical Plate 100065-0 is a Class II device 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 B5231000650), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB5231000650 UDI-DI	Date7 Apr 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK113170	Date6 Apr 2012Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K113170

Across registries

2 registries list this device

FDA 510(k) K113170 decided 6 Apr 2012 Active
FDA GUDID UDI-DI B5231000650 listed 7 Apr 2017 Listed

Timeline

2 dated events

6 Apr 2012 Cleared FDA 510(k) K113170
7 Apr 2017 Listed FDA GUDID B5231000650

Coverage

1 jurisdiction

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Withdrawn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: 100065-0

Primary DI / UDI-DI: B5231000650
510(k) Number: K113170
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

Other devices from Eisertech, LLC

See all devices from Eisertech, LLC →

Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)