DEVICE: OsteoCentric Headless Compression System Obturator (00850015496295)

Device Identifier (DI) Information

OsteoCentric Headless Compression System Obturator
EX01-0005
In Commercial Distribution
EX01-0005
Osteocentric Technologies, Inc.
00850015496295
GS1

1
089645059 *Terms of Use
Headless Compression System Obturator
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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?
33997 Surgical drill guide obturator
A surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a high-grade stainless steel. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FZX Guide, Surgical, Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K200259 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

dc7bc34c-05e0-4924-87ac-48b7febae76c
January 06, 2025
3
February 15, 2023
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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
1 800-969-0639
quality@osteocentric.com
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