213-63-26

GUDID 10885862059819

AXIAL PATELLA REAMER 26MM INSET BLADE

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

Primary Device ID	10885862059819
NIH Device Record Key	c86f666a-0b75-41a6-bb21-8b5a776bd032
Commercial Distribution Status	In Commercial Distribution
Version Model Number	213-63-26
Catalog Number	213-63-26
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	false
Serial Number	true
Manufacturing Date	false
Expiration Date	true
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

Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter
Width	26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862059819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K933610

FDA Product Code

JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-09-02
Device Publish Date	2022-08-25

Devices Manufactured by Exactech, Inc.

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10885862595461 - Equinoxe	2024-04-22 PHx Humeral Plate Compression Screw Caddy
10885862595478 - Equinoxe	2024-04-22 PHx Humeral Plate Locking Screw Caddy
10885862595485 - Equinoxe	2024-04-22 PHx Humeral Plate 6.5mm Screw Caddy
10885862628947 - EXACTECHGPS	2024-04-15 Station V3