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 Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis Total wrist prosthesis 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