DEVICE: Sierra™ (10889981043971)

Device Identifier (DI) Information

Sierra™
51-4534
Not in Commercial Distribution
51-4534
SEASPINE ORTHOPEDICS CORPORATION
10889981043971
GS1
September 02, 2016
1
079840876 *Terms of Use
Sierra Extended Tab Screw, 04.5 x 34mm
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61235 Cannulated surgical drill bit, single-use
A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062934 000
No CLOSE

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: 4.5 Dia X 34mm
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Device Record Status

22289e9f-5155-4d8d-b04b-428953662792
November 28, 2022
6
September 24, 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(866)942-8698
custsvcspine@seaspine.com
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