DEVICE: PE.R.I.™LOWER EXT PLATE, FIBULA COMPOSITE (00887868036828)
Device Identifier (DI) Information
PE.R.I.™LOWER EXT PLATE, FIBULA COMPOSITE
8141-23-009
In Commercial Distribution
814123009
Biomet Orthopedics, LLC
8141-23-009
In Commercial Distribution
814123009
Biomet Orthopedics, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
61573 | Orthopaedic fixation plate, non-bioabsorbable, non-sterile |
A non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRS | Plate, fixation, bone |
HWC | Screw, fixation, bone |
KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
LXT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE |
JDW | PIN, FIXATION, THREADED |
HTY | PIN, FIXATION, SMOOTH |
HTN | WASHER, BOLT NUT |
HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
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 |
---|
Device Size Text, specify: 9H |
Device Record Status
ba642c36-fcc0-4c67-9191-24f9ae8abc63
February 19, 2024
6
March 17, 2017
February 19, 2024
6
March 17, 2017
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)348-9500
customerservice@zimmerbiomet.com
customerservice@zimmerbiomet.com