01-003-04-0006

GUDID 10885862267047

Calcar Planer Blade, 2’’

Exactech, Inc.

Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable

Primary Device ID	10885862267047
NIH Device Record Key	b5037109-fe91-4e46-b74b-93e40fae9d18
Commercial Distribution Status	In Commercial Distribution
Version Model Number	01-003-04-0006
Catalog Number	01-003-04-0006
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

Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch
Outer Diameter	2 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862267047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K140674

FDA Product Code

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