DEVICE: Alteon (10885862513908)

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Device Record History
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Device Identifier (DI) Information
Alteon
191-03-15
In Commercial Distribution
191-03-15
Exactech, Inc.
10885862513908
GS1

1
157565946 *Terms of Use
ALT HA S COMP BRCH SZ 15
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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?
36167 Orthopaedic broach
A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
MEH Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWL Prosthesis, hip, hemi-, femoral, metal
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
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
Device Size Text, specify: SZ 15
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Device Record Status
52b7c307-0040-4589-b0ff-83e999e4fdd5
August 26, 2022
1
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

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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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