Implant Holder with Drill Guides W18 x H09 mm RO0825I309

GUDID B806RO0825I3090

Implant Holder with Drill Guides W18 x H09 mm

Spineup, Inc.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device IDB806RO0825I3090
NIH Device Record Keyd56eb4c4-52f4-4346-adde-5f00ad4bc04e
Commercial Distribution StatusIn Commercial Distribution
Brand NameImplant Holder with Drill Guides W18 x H09 mm
Version Model NumberRO0825I309
Catalog NumberRO0825I309
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
HIBCCB806RO0825I3090 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

Moist Heat or Steam Sterilization


[B806RO0825I3090]

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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