187-04-13

GUDID 10885862238351

ACETABULAR AUGMENT RASP, GROUP 4, LARGE, 13mm

Exactech, Inc.

Bone file/rasp, manual, reusable

• Primary Device ID: 10885862238351
• NIH Device Record Key: 3d9f4d05-bbcf-4254-b96b-8b1d47fa8e98
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 187-04-13
• Catalog Number: 187-04-13
• 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
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862238351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101761

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

[10885862238351]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-27
• Device Publish Date: 2022-09-19

Devices Manufactured by Exactech, Inc.

• 10885862650450 - Truliant: 2025-02-28 Special LBS III Femoral Paddle Extension, Left
• 10885862650467 - Truliant: 2025-02-28 Special LBS III Femoral Paddle Extension, Right
• 10885862636416 - Truliant: 2025-02-07 Special Extended Femoral IM Rod
• 10885862636423 - Truliant: 2025-02-07 Special Extended Femoral IM Rod
• 10885862636430 - Truliant: 2025-02-07 Special Extended Femoral IM Rod Slap Hammer Adapter
• 10885862653260 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 1
• 10885862653277 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 2
• 10885862653284 - Truliant: 2025-01-16 Special Universal Baseplate Tibial Trial, Size 3