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ACE Medical ACE07-30S EX

by Ebner Medical LLC

ACE Medical ACE07-30S EX is a Class II device made by Ebner Medical LLC, cleared under FDA 510(k) K200387 on 21 Jul 2020 and listed in FDA GUDID since 8 Jun 2021 (UDI-DI 00840217905237), active as of 2 Nov 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 2 Nov 2026

Documents

510(k) K200387

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840217905237 UDI-DI Date8 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200387 Date21 Jul 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200387 decided 21 Jul 2020 Active
  • FDA GUDID UDI-DI 00840217905237 listed 8 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200387
  2. Listed FDA GUDID 00840217905237

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ACE Medical
Generic name
Spinal rongeur
Model / Ref / Catalog
ACE07-30S EX
Primary DI / UDI-DI
00840217905237
510(k) Number
FDA product code
HAE
GMDN term
Spinal rongeur
Device class
Class II
Regulation number
882.4840
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 7 Inch
Width — 3 Millimeter

Related devices

Category: Spinal rongeur

Cleared under the same submission (K200387)

and 8 more cleared under K200387

Other devices from Ebner Medical LLC

See all devices from Ebner Medical LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)