DEVICE: NA (10885862267047)

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Device Record History
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Device Identifier (DI) Information
NA
01-003-04-0006
In Commercial Distribution
01-003-04-0006
Exactech, Inc.
10885862267047
GS1

1
157565946 *Terms of Use
Calcar Planer Blade, 2’’
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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?
45114 Bone-resection orthopaedic reamer, reusable
An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWL Prosthesis, hip, hemi-, femoral, metal
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
MEH Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K140674 000
K162732 000
K182462 000
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Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 2 Inch
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Device Record Status
b5037109-fe91-4e46-b74b-93e40fae9d18
October 04, 2023
3
August 18, 2022
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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