Implant Holder with Drill Guides W20 x H09 mm RO0835I409

GUDID B806RO0835I4090

Implant Holder with Drill Guides W20 x H09 mm

Spineup, Inc.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device IDB806RO0835I4090
NIH Device Record Key4daa1c47-ba49-472e-8178-713d1942465a
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant Holder with Drill Guides W20 x H09 mm
Version Model NumberRO0835I409
Catalog NumberRO0835I409
Company DUNS116999578
Company NameSpineup, 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 Usefalse
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

Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech
Phone786-910-0234
Emailcontact@upgroup.tech

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB806RO0835I4090 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


[B806RO0835I4090]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-09
Device Publish Date2024-10-01

Devices Manufactured by Spineup, Inc.

B806RO0015QCAZ0 - Quick Connect Awl2025-03-04 Quick Connect Aw
B806RO1877AF1118X140 - Anatomic Rasp with Stop 18x14, H11mm2025-03-04 Anatomic Rasp with Stop 18x14, H11mm
B806GN0001SSMZ0 - Small Slotted Mallet2024-10-22 Small Slotted Mallet
B806GN0004SAQC0 - Small AO Quick Connect Handle2024-10-22 Small AO Quick Connect Handle
B806GN0005MAQC0 - Medium AO Quick Connect Handle2024-10-22 Medium AO Quick Connect Handle
B806GN0006LAQC0 - Large AO Quick Connect Handle2024-10-22 Large AO Quick Connect Handle
B806GN0010SRZZ0 - Romero Cervical Screw Remover2024-10-22 Cervical Screw Remover
B806GN0011T08S0 - Cervical Screw Driver Shaft Straight Quick Connect2024-10-22 Cervical Screw Driver Shaft Straight Quick Connect

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.