DEVICE: N/A (00841036199722)

Device Identifier (DI) Information

N/A
SP-1892
In Commercial Distribution
SP-1892
BIOMET MICROFIXATION, INC
00841036199722
GS1

1
046189866 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
56642 Orthopaedic bone screw, non-bioabsorbable, non-sterile
A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
HBW FASTENER, PLATE, CRANIOPLASTY
GXR COVER, BURR HOLE
JEY PLATE, BONE
GWO Plate, cranioplasty, preformed, alterable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121589 000
K121624 000
K953385 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
No Device Sizes
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Device Record Status

71ab0e09-213c-4ef9-9991-9b2e7020d216
May 30, 2025
5
October 11, 2015
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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
Yes
No
No CLOSE

Customer Contact

[?]
+1(904)741-4400
FXJAX-ORDERS@ZIMMERBIOMET.COM
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