Implant Holder with Drill Guides W14 x H10 mm RO0806I110

GUDID B806RO0806I1100

Implant Holder with Drill Guides W14 x H10 mm

Spineup, Inc.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device IDB806RO0806I1100
NIH Device Record Keyac161e5b-ed40-4f16-8a9e-9e75a73b4526
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant Holder with Drill Guides W14 x H10 mm
Version Model NumberRO0806I110
Catalog NumberRO0806I110
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
HIBCCB806RO0806I1100 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

Moist Heat or Steam Sterilization


[B806RO0806I1100]

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.

B806ISRO1214L08CA10 - ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH082025-12-12 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers
B806ISRO1420L13CA10 - ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH132025-12-12 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers
B806ISRO1620A12CA10 - ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH122025-12-12 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers
B806ISRO1214A04CB10 - ROMERO CERVICAL CAGE, W14xD12xH042025-12-11 The Romero Cervical Cage is an anterior cervical interbody device consisting of a PEEK interbody cage with radiographic markers
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

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.