Curved Lenke Probe 101-0036

GUDID 00810097803510

Curved Lenke Probe

Osteocentric Technologies, Inc.

Internal spinal fixation procedure kit, reusable
Primary Device ID00810097803510
NIH Device Record Key3a7d346d-1502-4562-b54a-39a7e53adf91
Commercial Distribution StatusIn Commercial Distribution
Brand NameCurved Lenke Probe
Version Model Number101-0036
Catalog Number101-0036
Company DUNS089645059
Company NameOsteocentric Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097803510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HXBProbe
OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


[00810097803510]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-13
Device Publish Date2024-12-05

Devices Manufactured by Osteocentric Technologies, Inc.

00810074306416 - 7.0mm Nut2025-07-02 7.0mm Nut
00810074306423 - 8.0mm Nut2025-07-02 8.0mm Nut
00816950025518 - 3.3mm Locking Screw Fastener ST 24mm2025-07-02 3.3mm Locking Screw Fastener ST 24mm
00816950025525 - 3.3mm Locking Screw Fastener ST 26mm2025-07-02 3.3mm Locking Screw Fastener ST 26mm
00816950025532 - 3.3mm Locking Screw Fastener ST 28mm2025-07-02 3.3mm Locking Screw Fastener ST 28mm
00816950025549 - 3.3mm Locking Screw Fastener ST 30mm2025-07-02 3.3mm Locking Screw Fastener ST 30mm
00816950025556 - 3.3mm Locking Screw Fastener ST 32mm2025-07-02 3.3mm Locking Screw Fastener ST 32mm
00816950025563 - 3.3mm Locking Screw Fastener ST 34mm2025-07-02 3.3mm Locking Screw Fastener ST 34mm

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