DEVICE: Novation (10885862033697)

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Device Record History
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Device Identifier (DI) Information
Novation
161-07-03
In Commercial Distribution
161-07-03
Exactech, Inc.
10885862033697
GS1

1
157565946 *Terms of Use
REAMER, EXTENDED TAPER, HUDSON, SIZE 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?
45115 Medullary canal orthopaedic reamer, rigid
An orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MEH Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K042842 000
K102487 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: SIZE 15
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Device Record Status
97cd8eed-3ef3-4500-b5c7-596766dd513b
September 02, 2022
1
August 25, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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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