DEVICE: "1.5MM" SYSTEM PLATE (00841036012618)

Device Identifier (DI) Information

"1.5MM" SYSTEM PLATE
01-7065
In Commercial Distribution
01-7065
BIOMET MICROFIXATION, INC
00841036012618
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?
46267 Cranioplasty plate, alterable
An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HBW FASTENER, PLATE, CRANIOPLASTY
JEY PLATE, BONE
GXR COVER, BURR HOLE
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

3f3b4a14-45d9-4bb8-9381-1c7a4823bee0
May 30, 2025
4
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
No
No
No CLOSE

Customer Contact

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