ACE Medical

FDA UDI

Class II (US FDA UDI)

by Ebner Medical Llc

Identity

Trade Name: ACE Medical FDA UDI
Generic Name: Spinal rongeur FDA UDI
Device Name: PVD Coated Black Foraminotomy Standard Curve Kerrison 8" 3mm Thin Footplate FDA UDI
Model / Reference: ACEFOR08-30 EX FDA UDI
Description: PVD Coated Black Foraminotomy Standard Curve Kerrison 8" 3mm Thin Footplate FDA UDI

Identifiers

Catalog Number: ACEFOR08-30 EX FDA UDI
Primary DI / UDI-DI: 00840217905268 FDA UDI
510(k) Number: K200387 FDA UDI
FDA Product Code: HAE FDA UDI
GMDN Term: Spinal rongeur FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4840 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 8 Inch FDA UDI
Width — 3 Millimeter FDA UDI

Category: Spinal rongeur

ACE Medical by Ebner Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal rongeur.

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Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
V. Mueller — STERIS CORPORATION · Class II
Boss Instruments — Boss Instruments, Ltd. · Class II

Cleared under the same submission

K200387 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ebner Medical Llc

Sources (1)

FDA UDI 4b643f14-c707-482e-a2af-9c5200f13f59 37 fields · synced Jun 1, 2026