Acumatch P Series 118-40-01

GUDID 10885862019349

Exactech, Inc.

Press-fit femoral stem prosthesis

• Primary Device ID: 10885862019349
• NIH Device Record Key: bb00de99-971e-4e53-8a69-d7a525ae5ee2
• Commercial Distribution Discontinuation: 2024-06-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Acumatch P Series
• Version Model Number: 118-40-01
• Catalog Number: 118-40-01
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 135 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862019349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051335

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-08-28
• Device Publish Date: 2015-08-10

On-Brand Devices [Acumatch P Series]

• 10885862019486: 118-41-07
• 10885862019479: 118-41-06
• 10885862019462: 118-41-05
• 10885862019455: 118-41-04
• 10885862019431: 118-41-02
• 10885862019424: 118-41-01
• 10885862019417: 118-41-00
• 10885862019400: 118-40-07
• 10885862019394: 118-40-06
• 10885862019387: 118-40-05
• 10885862019370: 118-40-04
• 10885862019363: 118-40-03
• 10885862019356: 118-40-02
• 10885862019349: 118-40-01
• 10885862019332: 118-40-00
• 10885862018939: 118-01-07
• 10885862018922: 118-01-06
• 10885862018915: 118-01-05
• 10885862018908: 118-01-04
• 10885862018892: 118-01-03
• 10885862018885: 118-01-02
• 10885862018878: 118-01-01
• 10885862018861: 118-01-00
• 10885862018809: 118-00-02
• 10885862018793: 118-00-01
• 10885862018786: 118-00-00
• 10885862017512: 114-01-06
• 10885862017505: 114-01-05
• 10885862017499: 114-01-04
• 10885862017482: 114-01-03
• 10885862017475: 114-01-02
• 10885862017468: 114-01-01
• 10885862017451: 114-01-00