145-01-01

GUDID 10885862027528

CONSTRAINED LINER DRIVER HEAD, 28mm & 32mm

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

Primary Device ID	10885862027528
NIH Device Record Key	1362328c-a363-442b-ad33-bf3b969cf539
Commercial Distribution Status	In Commercial Distribution
Version Model Number	145-01-01
Catalog Number	145-01-01
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 Dimensions

Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter
Lumen/Inner Diameter	28 Millimeter
Lumen/Inner Diameter	32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862027528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K040601

FDA Product Code

KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer