DEVICE: NA (10885862016850)

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Device Record History
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Device Identifier (DI) Information
NA
113-03-01
In Commercial Distribution
113-03-01
Exactech, Inc.
10885862016850
GS1

1
157565946 *Terms of Use
FEMORAL HEAD IMPACTOR
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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?
32856 Orthopaedic implant impactor, reusable
A metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MEH Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
OQI Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K032964 000
K041906 000
K050398 000
K051682 000
K060107 000
K103012 000
K173583 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

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Size Type Text
No Device Sizes
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Device Record Status
cfbc770d-e869-4247-a053-91da6ef4c102
January 20, 2023
2
July 28, 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

[?]
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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