Integra® Freedom Wrist Arthroplasty System 348340E

GUDID M268348340E1

The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpal plate and implant.

Ascension Orthopedics, Inc.

Total wrist prosthesis

• Primary Device ID: M268348340E1
• NIH Device Record Key: 2ba87b19-7e0b-4292-af31-081996df0dc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Freedom Wrist Arthroplasty System
• Version Model Number: 348340E
• Catalog Number: 348340E
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, 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: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: 800-654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 * Avoid contact with any objects that may damage the surface finish.
• Special Storage Condition, Specify: Between 0 and 0 *Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780067290 [Primary]
HIBCC	M268348340E1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132250

FDA Product Code

• JWJ: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

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: 2021-03-04
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® Freedom Wrist Arthroplasty System]

• M2483481951: Integra® Freedom Wrist Arthroplasty System Anti-Rotation Pin
• M2483481861: Integra® Freedom Wrist Arthroplasty System Radial Trial Remover
• M2483481841: Integra® Freedom Wrist Arthroplasty System Radial Impactor
• M2483481811: Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 4, Right
• M2483481781: Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 4, Left
• M2483481751: Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 3, Right
• M2483481721: Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 3, Left
• M2483481691: Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 2, Right
• M2483481661: Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 2, Left
• M2483481631: Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 1, Right
• M2483481601: Integra® Freedom Wrist Arthroplasty System Radial Broach, Size 1, Left
• M2483481561: Integra® Freedom Wrist Arthroplasty System Box Punch, Right
• M2483481541: Integra® Freedom Wrist Arthroplasty System Box Punch, Left
• M2483481461: Integra® Freedom Wrist Arthroplasty System Radial Resection Guide Size 3
• M2483481421: Integra® Freedom Wrist Arthroplasty System Radial IM Guide Rod
• M2483481411: Integra® Freedom Wrist Arthroplasty System Radial IM Guide Rod
• M2483481401: Integra® Freedom Wrist Arthroplasty System Radial Template, Size 2
• M2483481391: Integra® Freedom Wrist Arthroplasty System Radial Template, Size 1
• M2483481381: Integra® Freedom Wrist Arthroplasty System Radial Score Guide
• M2483481061: Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 3 Left
• M2483481051: Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 2 Right
• M2483481041: Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 2 Left
• M2483481031: Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 1 Right
• M2483481021: Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 1 Left
• M2483481011: Integra® Freedom Wrist Arthroplasty System 2.5mm Hex Driver
• M2483480951: Integra® Freedom Wrist Arthroplasty System T15 Star Driver
• M2483480941: Integra® Freedom Wrist Arthroplasty System 4.0mm Stop Drill Bit
• M2483480931: Integra® Freedom Wrist Arthroplasty System 3.5mm Cannulated Drill Bit
• M2483480921: Integra® Freedom Wrist Arthroplasty System 2.5mm Cannulated Drill Bit
• M2483480911: Integra® Freedom Wrist Arthroplasty System K-Wire Depth Gauge
• M2483480901: Integra® Freedom Wrist Arthroplasty System 0.54" (1.4 mm) K-Wire
• M2483480891: Integra® Freedom Wrist Arthroplasty System Tissue Protective Sleeve
• M2483480881: Integra® Freedom Wrist Arthroplasty System Carpal Poly Impactor
• M2483480831: Integra® Freedom Wrist Arthroplasty System Carpal Plate Impactor
• M2483480811: Integra® Freedom Wrist Arthroplasty System Carpal Cement Reamer
• M2483480631: Integra® Freedom Wrist Arthroplasty System Hamate Feeler
• M2483480601: Integra® Freedom Wrist Arthroplasty System Carpal Guide Bar
• M2483480591: Integra® Freedom Wrist Arthroplasty System K-Wire Sleeve
• M2483480541: Integra® Freedom Wrist Arthroplasty System Carpal Sizer
• M2483480521: Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 3, +4 mm
• M2483480511: Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 3, +2 mm
• M2483480501: Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 3, Standard
• M2483480491: Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 2, +4 mm
• M2483480481: Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 2, +2 mm
• M2483480471: Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 2, Standard
• M2483480461: Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 1, +4 mm
• M2483480451: Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 1, +2 mm
• M2483480441: Integra® Freedom Wrist Arthroplasty System Carpal Poly Trial Size 1, Standard
• M2483480431: Integra® Freedom Wrist Arthroplasty System Carpal Plate Trial, Size 3
• M2483480421: Integra® Freedom Wrist Arthroplasty System Carpal Plate Trial, Size 2