209-71-14

GUDID 10885862056764

TIBIAL STEM EXTENSION DRILL, GUIDE, 14mm

Exactech, Inc.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID10885862056764
NIH Device Record Key509e5ee8-9a25-464e-91fa-9d5a2c82db32
Commercial Distribution StatusIn Commercial Distribution
Version Model Number209-71-14
Catalog Number209-71-14
Company DUNS157565946
Company NameExactech, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter
Lumen/Inner Diameter14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862056764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

[10885862056764]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-02
Device Publish Date2022-08-25

Devices Manufactured by Exactech, Inc.

10885862634108 - Equinoxe2024-07-16 Special Truliant Spike EM Tibial Guide
10885862634115 - Equinoxe2024-07-16 Special Spiked Tibial Resector Extractor Hook
10885862635044 - Equinoxe2024-07-16 Special Small Spiked Humeral Resection Cover
10885862635051 - Equinoxe2024-07-16 Special Medium Spiked Humeral Resection Cover
10885862635068 - Equinoxe2024-07-16 Special Large Spiked Humeral Resection Cover
10885862635143 - Equinoxe2024-07-16 Special Laser Cage Trephine Drill. 0-8 Deg, Peripheral Pegs
10885862635150 - Equinoxe2024-07-16 Special Laser Cage Trephone Drill. 0-8 Deg, Central Cage
10885862630704 - Equinoxe2024-06-20 Special Modular rTSA 32mm Circular Reamer
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.