ACE Medical Company

FDA UDI

Class II (US FDA UDI)

by Ebner Medical Llc

Identity

Trade Name: ACE Medical Company FDA UDI
Generic Name: Spinal rongeur FDA UDI
Device Name: PVD Coated Black Bayonet Kerrison 5" WL, 2mm Thin Footplate FDA UDI
Model / Reference: ACEBAY05-20T FDA UDI
Description: PVD Coated Black Bayonet Kerrison 5" WL, 2mm Thin Footplate FDA UDI

Identifiers

Catalog Number: ACEBAY05-20T FDA UDI
Primary DI / UDI-DI: 00840217900157 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 — 5 Inch FDA UDI
Width — 2 Millimeter FDA UDI

Category: Spinal rongeur

ACE Medical Company 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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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 c8554374-df5c-4991-8382-8491ef1d0614 37 fields · synced Jun 1, 2026