Novation Element 165-00-08

GUDID 10885862035530

BROACH, SIZE 8

Exactech, Inc.

Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach

• Primary Device ID: 10885862035530
• NIH Device Record Key: d009eba5-da85-41e6-a1e6-c37934a40034
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novation Element
• Version Model Number: 165-00-08
• Catalog Number: 165-00-08
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862035530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080980

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

[10885862035530]

Moist Heat or Steam Sterilization

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

On-Brand Devices [Novation Element]

• 10885862280633: NV ELEMENT STARTER RASP SZ 8 WITH CHIP BREAKERS
• 10885862280626: NV ELEMENT STARTER RASP SZ 7 WITH CHIP BREAKERS
• 10885862249357: BROACH, NOVATION ELEMENT, SIZE 18
• 10885862249340: BROACH, NOVATION ELEMENT, SIZE 17
• 10885862249333: BROACH, NOVATION ELEMENT, SIZE 16
• 10885862249326: BROACH, NOVATION ELEMENT, SIZE 15
• 10885862249319: BROACH, NOVATION ELEMENT, SIZE 14
• 10885862249302: BROACH, NOVATION ELEMENT, SIZE 13
• 10885862249296: BROACH, NOVATION ELEMENT, SIZE 12
• 10885862249289: BROACH, NOVATION ELEMENT, SIZE 11
• 10885862249272: BROACH, NOVATION ELEMENT, SIZE 10
• 10885862249265: BROACH, NOVATION ELEMENT, SIZE 9
• 10885862249258: BROACH, NOVATION ELEMENT, SIZE 8
• 10885862204165: NV ELEM RO NT X/O SZ 13 NECK TRIAL
• 10885862204141: NV ELEM RO NT X/O SZ 11 NECK TRIAL
• 10885862204134: NV ELEM RO NT X/O SZ 10 NECK TRIAL
• 10885862204127: NV ELEM RO NT X/O SZ 9 NECK TRIAL
• 10885862204110: NV ELEM RO NT X/O SZ 8 NECK TRIAL
• 10885862204103: NV ELEM RO NT S/O SZ 13 NECK TRIAL
• 10885862204097: NV ELEM RO NT S/O SZ 12 NECK TRIAL
• 10885862204073: NV ELEM RO NT S/O SZ 10 NECK TRIAL
• 10885862204066: NV ELEM RO NT S/O SZ 9 NECK TRIAL
• 10885862204059: NV ELEM RO NT S/O SZ 8 NECK TRIAL
• 10885862035721: TEMPLATE, STEM, SIZE 8-18
• 10885862035691: TRIAL, NECK, EXTENDED OFFSET, SIZE 14-18
• 10885862035684: TRIAL, NECK, EXTENDED OFFSET, SIZE 11-13
• 10885862035677: TRIAL, NECK, EXTENDED OFFSET, SIZE 8-10
• 10885862035660: TRIAL, NECK, SIZE 14-18
• 10885862035653: TRIAL, NECK, SIZE 11-13
• 10885862035646: TRIAL, NECK, SIZE 8-10
• 10885862035639: BROACH, SIZE 18
• 10885862035622: BROACH, SIZE 17
• 10885862035615: BROACH, SIZE 16
• 10885862035608: BROACH, SIZE 15
• 10885862035592: BROACH, SIZE 14
• 10885862035585: BROACH, SIZE 13
• 10885862035578: BROACH, SIZE 12
• 10885862035561: BROACH, SIZE 11
• 10885862035547: BROACH, SIZE 9
• 10885862035530: BROACH, SIZE 8
• 10885862035394: TEMPLATE, SIZE 08/18