103-07-01

GUDID 10885862012449

IMPACTOR, FEMORAL STEM

Exactech, Inc.

Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor

Primary Device ID	10885862012449
NIH Device Record Key	2672bd4b-8a98-45f0-80d6-a88f3b6c5136
Commercial Distribution Status	In Commercial Distribution
Version Model Number	103-07-01
Catalog Number	103-07-01
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	false
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	10885862012449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K041906

FDA Product Code

LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented