AcuMatch 113-01-10

GUDID 10885862016775

BROACH, MODIFIED FIT, SIZE 0

Exactech, Inc.

Orthopaedic broach

• Primary Device ID: 10885862016775
• NIH Device Record Key: cbcb0984-50b6-4738-ba74-e92028639630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuMatch
• Version Model Number: 113-01-10
• Catalog Number: 113-01-10
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10885862016775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041906

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

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

[10885862016775]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

On-Brand Devices [AcuMatch]

• 10885862616968: SPI-044143-70
• 10885862616951: SPI-044143-68
• 10885862616944: SPI-044143-66
• 10885862616920: SPI-044143-62
• 10885862616913: SPI-044143-60
• 10885862616906: SPI-044143-58
• 10885862616890: SPI-044143-56
• 10885862616883: SPI-044143-54
• 10885862616876: SPI-044143-52
• 10885862616869: SPI-044143-50
• 10885862616852: SPI-044143-48
• 10885862616845: SPI-044143-46
• 10885862616838: SPI-044143-44
• 10885862616821: SPI-044143-42
• 10885862096234: ACUMATCH M-SERIES TEMPLATE SET
• 10885862096227: M-SERIES 12/14 TEMPLATE
• 10885862096159: P-SERIES COLLARED FEMORAL STEM TEMPLATE
• 10885862096142: P-SERIES COLLARLESS FEMORAL STEM TEMPLATE
• 10885862096104: C-SERIES CEM FEMORAL STEM TEMPLATE SET
• 10885862030597: TEMPLATE, STEM, M-SERIES
• 10885862030573: M-SERIES INSTRUMENT CASE 6
• 10885862030566: M-SERIES INSTRUMENT CASE 5
• 10885862030559: M-SERIES INSTRUMENT CASE 4
• 10885862030542: M-SERIES INSTRUMENT CASE 3
• 10885862030535: M-SERIES INSTRUMENT CASE 2
• 10885862030528: M-SERIES INSTRUMENT CASE 1
• 10885862028907: IMPACTOR ALIGNMENT GUIDE, M-SERIES
• 10885862028839: NECK IMPACTOR, M-SERIES
• 10885862028822: STEM IMPACTOR, M-SERIES
• 10885862028808: OSTEOTOMY GUIDE, M-SERIES
• 10885862020482: TEMPLATE, CUP, A-SERIES
• 10885862020444: ACUMATCH REAMER TRAY
• 10885862020390: ACUMATCH ACET. INST TRAY
• 10885862017420: ACUMATCH FEMORAL INSTRUMENT TRAY #2
• 10885862017413: ACUMATCH FEMORAL INSTRUMENT TRAY #1
• 10885862016072: TEMPLATE, ACETABULAR CUP, ACUMATCH
• 10885862015570: ACUMATCH BROACH HANDLE
• 10885862013101: BIPOLAR INSTRUMENT CASE
• 10885862012807: BIPOLAR ASSEMBLY PLIERS
• 10885862012791: FEMORAL HEAD TEMPLATE, BIPOLAR
• 10885862012784: TRIAL HANDLE ADAPTOR, BIPOLAR
• 10885862012777: TRIAL HANDLE, BIPOLAR, ANGLED
• 10885862012760: DISASSEMBLY TOOL, BIPOLAR
• 10885862012753: TRIAL HANDLE, BIPOLAR, STRAIGHT
• 10885862012494: TRIAL HANDLE ADAPTOR, BIPOLAR
• 10885862012180: IMPACTOR, UNIPOLAR HEAD
• 10885862011008: LINER EXTRACTOR, A-SERIES
• 10885862009616: TEMPLATE, UNIPOLAR & BIPOLAR HEAD
• 10885862028945: IMPACTOR, HEAD, M-SERIES
• 10885862028921: EXTRACTOR HOOK, SMALL