ACTERA HIP STEM HES-034-07UH

GUDID M572HES03407UH011

ACTERA HIP STEM UNCOLLARED SZ 7, HIGH OFFSET

Conformis, Inc.

Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece Coated femoral stem prosthesis, one-piece

• Primary Device ID: M572HES03407UH011
• NIH Device Record Key: ef7aad3f-5a90-4d5b-ad87-69032bdb0d4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTERA HIP STEM
• Version Model Number: HES-034-07UH-01
• Catalog Number: HES-034-07UH
• Company DUNS: 808821883
• Company Name: Conformis, 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com

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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M572HES03407UH011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221104

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-17
• Device Publish Date: 2022-10-07

On-Brand Devices [ACTERA HIP STEM]

• M572HES03402CS011: ACTERA HIP STEM COLLARED SZ 2, STD OFFSET
• M572HES03409CH011: ACTERA FEMORAL HIP STEM COLLARED SZ 9, HIGH OFFSET
• M572HES03408CS011: ACTERA FEMORAL HIP STEM COLLARED SZ 8, STD OFFSET
• M572HES03408CH011: ACTERA FEMORAL HIP STEM COLLARED SZ 8, HIGH OFFSET
• M572HES03407US011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 7, STD OFFSET
• M572HES03407CS011: ACTERA FEMORAL HIP STEM COLLARED SZ 7, STD OFFSET
• M572HES03407CH011: ACTERA FEMORAL HIP STEM COLLARED SZ 7, HIGH OFFSET
• M572HES03406US011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 6, STD OFFSET
• M572HES03406UH011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 6, HIGH OFFSET
• M572HES03405US011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 5, STD OFFSET
• M572HES03405UH011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 5, HIGH OFFSET
• M572HES03405CS011: ACTERA FEMORAL HIP STEM COLLARED SZ 5, STD OFFSET
• M572HES03405CH011: ACTERA FEMORAL HIP STEM COLLARED SZ 5, HIGH OFFSET
• M572HES03404US011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 4, STD OFFSET
• M572HES03404UH011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 4, HIGH OFFSET
• M572HES03404CS011: ACTERA HIP STEM COLLARED SZ 4, STD OFFSET
• M572HES03404CH011: ACTERA HIP STEM COLLARED SZ 4, HIGH OFFSET
• M572HES03403US011: ACTERA HIP STEM UNCOLLARED SZ 3 STD OFFSET
• M572HES03403UH011: ACTERA HIP STEM UNCOLLARED SIZE 3 HIGH OFFSET
• M572HES03403CS011: ACTERA HIP STEM COLLARED SZ 3, STD OFFSET
• M572HES03403CH011: ACTERA HIP STEM COLLARED SZ 3, HIGH OFFSET
• M572HES03402US011: ACTERA HIP STEM UNCOLLARED SZ 2, STD OFFSET
• M572HES03402UH011: UNCOLLARED SIZE 2 HIGH OFFSET
• M572HES03402CH011: ACTERA HIP STEM COLLARED SZ 2, HIGH OFFSET
• M572HES03409UH011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 9, HIGH OFFSET
• M572HES03408US011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 8, STD OFFSET
• M572HES03408UH011: ACTERA FEMORAL HIP STEM UNCOLLARED SZ 8, HIGH OFFSET
• M572HES03407UH011: ACTERA HIP STEM UNCOLLARED SZ 7, HIGH OFFSET