DEVICE: ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS (05055662928075)

Device Identifier (DI) Information

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
OS309005
In Commercial Distribution
OS309005
ORTHO SOLUTIONS HOLDINGS LIMITED
05055662928075
GS1

1
218648211 *Terms of Use
6.5/8.0 SCREWDRIVER SHANK
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical screwdriver, reusable A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110895 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

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Size Type Text
No Device Sizes
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Device Record Status

dde54633-43d2-4982-940a-02cd4d2b308e
October 05, 2018
5
April 27, 2016
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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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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

[?]
+441621843599
quality@orthosol.com
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