Implant Holder with Drill Guides W20 x H06 mm RO0832I406

GUDID B806RO0832I4060

Implant Holder with Drill Guides W20 x H06 mm

Spineup, Inc.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device IDB806RO0832I4060
NIH Device Record Keyfdce5ca0-e9c9-4ce4-959e-7a9bbf0aaa7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant Holder with Drill Guides W20 x H06 mm
Version Model NumberRO0832I406
Catalog NumberRO0832I406
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
HIBCCB806RO0832I4060 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

Moist Heat or Steam Sterilization


[B806RO0832I4060]

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.

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B806ISRO1214A05CB10 - ROMERO CERVICAL CAGE, W14xD12xH052025-12-11 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers
B806ISRO1214A06CB10 - ROMERO CERVICAL CAGE, W14xD12xH062025-12-11 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers
B806ISRO1214A07CB10 - ROMERO CERVICAL CAGE, W14xD12xH072025-12-11 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers
B806ISRO1214A08CB10 - ROMERO CERVICAL CAGE, W14xD12xH082025-12-11 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers

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