DEVICE: NA (10885862238382)

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Device Record History
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Device Identifier (DI) Information
NA
187-05-13
Not in Commercial Distribution
187-05-13
Exactech, Inc.
10885862238382
GS1
June 13, 2024
1
157565946 *Terms of Use
ACETABULAR AUGMENT RASP, GROUP 5, LARGE, 13mm
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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?
35559 Bone file/rasp, manual, reusable
A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
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 [?]
K101761 000
K113609 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: LARGE
Device Size Text, specify: (proximal thickness of the rasp)
Depth: 13 Millimeter
Device Size Text, specify: GROUP 5
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Device Record Status
69d44b5f-fc87-4abb-8bad-3c9932e66c0e
September 04, 2025
2
September 19, 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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