DEVICE: INSTRUMENT (07613327208047)
Device Identifier (DI) Information
INSTRUMENT
1020-2100
In Commercial Distribution
1020-2100
Howmedica Osteonics Corp.
1020-2100
In Commercial Distribution
1020-2100
Howmedica Osteonics Corp.
ACCOLADE C DISTAL SIZER
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
No | |
No | |
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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? |
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44877 | Ligament graft sizer, noninvasive |
A surgical instrument that contains a series of holes of varying dimensions/sizes intended to be used in orthopaedic surgery [e.g., in anterior cruciate ligament (ACL) reconstruction surgery] to measure the size/diameter of a harvested graft to be implanted. It is used ex vivo [e.g., on the preparation table of the operating room (OR)] on a harvested graft. The measurement is subsequently used to determine the diameter of the tunnel drilled into the operative site (e.g., distal femur) for acceptance of the new graft. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
KWL | Prosthesis, hip, hemi-, femoral, metal |
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
HWC | Screw, fixation, bone |
MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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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No Device Sizes |
Device Record Status
59b2ead8-96d2-483b-9227-b5c1c5a4ec23
September 27, 2023
4
September 24, 2016
September 27, 2023
4
September 24, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined