OSSIO® Compression Screw Instruments For 4.0 mm Screws THN00057

GUDID 07290017630144

OSSIO® Compression Screw Instruments For 4.0 mm Screws. Package contains: 3 K-wires, 1 Drill Guide, 1 Drill Bit , 1 Tap, 1 Depth Gauge-Countersink, 1 Screwdriver, 1 AO Handle.

OSSIO LTD

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID07290017630144
NIH Device Record Key0dc562d3-01cc-4a78-8e5b-91afa60a6121
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSIO® Compression Screw Instruments For 4.0 mm Screws
Version Model NumberTHN00057
Catalog NumberTHN00057
Company DUNS600505107
Company NameOSSIO LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io
Phone1-833-781-7373
Emailcustomer_service@ossio.io

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS107290017630144 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-26
Device Publish Date2021-02-18

Devices Manufactured by OSSIO LTD

07290019361022 - OSSIOfiber® Trimmable Fixation Nail System, Cannulated2024-07-08 OSSIOfiber® Trimmable Fixation Nail System, 4.0x100mm, Cannulated. Package contains: 1 Implant, and 1 instrument pack.
07290017630670 - OSSIOfiber® Compression Staple System2024-05-24 OSSIOfiber® Compression Staple System, 9 x 10 mm. Package contains: 1 Implant, and 1 Instrument pack.
07290019361008 - OSSIOfiber® Compression Staple2024-05-24 OSSIOfiber® Compression Staple, 9X10 mm. Package contains: 1 Implant.
07290019361015 - OSSIOfiber® Compression Staple2024-05-24 OSSIOfiber® Compression Staple, 11X10 mm. Package contains: 1 Implant.
07290019361039 - OSSIOfiber® Compression Staple System2024-05-24 OSSIOfiber® Compression Staple System, 11 x 10 mm Package contains: 1 Implant, and 1 Instrument pack.
07290017630700 - OSSIOfiber® Compression Staple System2024-05-16 OSSIOfiber® Compression Staple System, 20 x 20 mm. Package contains: 1 Implant, and 1 Instrument pack.
07290017630717 - OSSIOfiber® Compression Staple System2024-05-16 OSSIOfiber® Compression Staple System, 25 x 22 mm Package contains: 1 Implant, and 1 Instrument pack.
07290019361060 - OSSIOfiber® Trimmable Fixation Nail, Cannulated2024-02-02 OSSIOfiber® Trimmable Fixation Nail, 4.0x100mm, Cannulated. Package contains: 1 Implant.

Trademark Results [OSSIO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSSIO
OSSIO
88021850 5921948 Live/Registered
Ossio LTD
2018-06-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.