X3 1236-2-848

GUDID 04546540638977

X3 Insert for ADM/ MDM

Howmedica Osteonics Corp.

Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner

• Primary Device ID: 04546540638977
• NIH Device Record Key: 015cf285-c2b3-412e-8515-1d6240c5471b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X3
• Version Model Number: 1236-2-848
• Catalog Number: 1236-2-848
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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: 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

• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 28 Millimeter
• Outer Diameter: 42 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540638977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093644

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [X3]

• 07613327026030: All-Poly Inserts
• 07613327026023: All-Poly Inserts
• 07613327026016: All-Poly Inserts
• 07613327026009: All-Poly Inserts
• 07613327025996: All-Poly Inserts
• 07613327025989: All-Poly Inserts
• 07613327025972: All-Poly Inserts
• 07613327025965: All-Poly Inserts
• 07613327025958: All-Poly Inserts
• 07613327025941: All-Poly Inserts
• 07613327025934: All-Poly Inserts
• 07613327025927: All-Poly Inserts
• 07613327025910: All-Poly Inserts
• 07613327025903: All-Poly Inserts
• 07613327025897: All-Poly Inserts
• 07613327025880: All-Poly Inserts
• 07613327025873: All-Poly Inserts
• 07613327025866: All-Poly Inserts
• 07613327025859: All-Poly Inserts
• 07613327025842: All-Poly Inserts
• 07613327025835: All-Poly Inserts
• 07613327025828: All-Poly Inserts
• 07613327025811: All-Poly Inserts
• 07613327025804: All-Poly Inserts
• 07613327025798: All-Poly Inserts
• 07613327025781: All-Poly Inserts
• 07613327025774: All-Poly Inserts
• 07613327025767: All-Poly Inserts
• 07613327025750: All-Poly Inserts
• 07613327025743: All-Poly Inserts
• 04546540665904: X3 Insert
• 04546540665898: X3 Insert for MDM Liner
• 04546540665881: X3 Insert for MDM Liner
• 04546540639059: X3 Insert for ADM/ MDM
• 04546540639042: X3 Insert
• 04546540639035: X3 Insert for ADM/ MDM
• 04546540639028: X3 Insert for ADM/ MDM
• 04546540639011: X3 Insert
• 04546540639004: X3 Insert for ADM/ MDM
• 04546540638991: X3 Insert for ADM/ MDM
• 04546540638984: X3 Insert
• 04546540638977: X3 Insert for ADM/ MDM