DEVICE: TC-PLUS (07611996036596)
Device Identifier (DI) Information
TC-PLUS
75006069
In Commercial Distribution
75006069
Smith & Nephew, Inc.
75006069
In Commercial Distribution
75006069
Smith & Nephew, Inc.
TC-PLUS PRIMARY / TC-PLUS REVISION
TIBIAL INSERT TC CS ULTRACONGRUENT 2/17
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Orthopaedic implant inserter/extractor | A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) into or out of the body. It is a robust instrument that has a mechanism (e.g., a sturdy hook that slots into one of the nail's locking screw holes, or a tapered/straight thread that locks into the inner material/thread of the implant's construct, or a clamp that will attach and/or lock to an exposed part of the implant). It is typically made of stainless steel/synthetic material and the surgeon can make strikes on the proximal end with a surgical hammer or mallet to insert/extract the implant. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
5735d05e-e5f5-47f0-a8a4-35f53c47d4ab
March 29, 2018
2
November 25, 2015
March 29, 2018
2
November 25, 2015
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 |
---|---|
No Secondary DIs found |
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)238-7538
GUDID@SMITH-NEPHEW.COM
GUDID@SMITH-NEPHEW.COM