EPIC FOOT PLATE SYSTEM 2000-3526

GUDID 00817577022195

Exactech, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

Primary Device ID	00817577022195
NIH Device Record Key	01a95a5e-9425-459e-80f5-1188f2a4a849
Commercial Distribution Status	In Commercial Distribution
Brand Name	EPIC FOOT PLATE SYSTEM
Version Model Number	A
Catalog Number	2000-3526
Company DUNS	157565946
Company Name	Exactech, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817577022195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153340

FDA Product Code

HRS	Plate, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00817577022195]

Moist Heat or Steam Sterilization

[00817577022195]

Moist Heat or Steam Sterilization

[00817577022195]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2020-01-30
Device Publish Date	2016-09-24

00817577023499	A
00817577023482	A
00817577023475	A
00817577023468	A
00817577023451	A
00817577023444	A
00817577023437	A
00817577023420	A
00817577023413	A
00817577023406	A
00817577023390	A
00817577023383	A
00817577023376	A
00817577023369	A
00817577023352	A
00817577023345	A
00817577023338	A
00817577023321	A
00817577023314	A
00817577023307	A
00817577023291	A
00817577023284	A
00817577023277	A
00817577023260	A
00817577023253	A
00817577023246	A
00817577023239	A
00817577023222	A
00817577023215	A
00817577023123	B
00817577022713	A
00817577022706	A
00817577022690	A
00817577022683	A
00817577022676	A
00817577022669	A
00817577022652	A
00817577022645	A
00817577022638	A
00817577022621	A
00817577022614	A
00817577022607	A
00817577022591	A
00817577022584	A
00817577022577	A
00817577022560	A
00817577022553	A
00817577022546	A
00817577022539	A
00817577022522	A

EPIC FOOT PLATE SYSTEM 2000-3526

GUDID 00817577022195

Exactech, Inc.

Device Identifiers

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

Sterilization

Device Entry Metadata

On-Brand Devices [EPIC FOOT PLATE SYSTEM]