DEVICE: HALLU-FIX (10381780043447)
Device Identifier (DI) Information
HALLU-FIX
117255SND
In Commercial Distribution
117255SND
NEWDEAL
117255SND
In Commercial Distribution
117255SND
NEWDEAL
The sterile HALLU-S plates are available in different sizes (left/right). They are both low profile titanium alloy plates dedicated to the first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation and they are contoured for optimal bone coverage. They are implanted using SNAP-OFF screws which exist in different diameters and sizes.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
---|---|---|---|---|
46647 | Orthopaedic fixation plate, non-bioabsorbable |
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRS | PLATE, FIXATION, BONE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K093781 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in dry place. |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 50.3mm length x 18.7mm width |
Device Record Status
6401b58e-341b-4e78-8ba0-bd578838fcb6
September 11, 2024
7
October 09, 2017
September 11, 2024
7
October 09, 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 |
---|---|
HIBCC | M248117255SND1 |
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