DEVICE: TiWedge™ (10381780237556)
Device Identifier (DI) Information
TiWedge™
TRL-1006-L02
Not in Commercial Distribution
Ascension Orthopedics, Inc.
TRL-1006-L02
Not in Commercial Distribution
Ascension Orthopedics, Inc.
The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dimensions of the osteotomy surface, and the desired amount of correction is achieved. The trial is to confirm that the implanted wedge will be congruent with the osteotomy surface to provide the most optimal site for ingrowth of bone into the wedge.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46479 | Surgical implant template, reusable |
A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWC | Screw, fixation, bone |
HRS | Plate, fixation, bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131360 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 70mm L handle ; 18.0 mm L x 16.0 mm W x 10.0 mm H Trial Wedge |
Device Record Status
c5e5b051-8b8f-47b8-9850-2725f90727ed
May 02, 2023
5
August 08, 2016
May 02, 2023
5
August 08, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | M269TRL1006L021 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)654-2873
custsvcnj@integralife.com
custsvcnj@integralife.com