FDA.reportPublic FDA data

Anatomic Trial Sizer with stop 14x16, H11mm

Primary DI
B806RO0327AB1114X160
Brand
Anatomic Trial Sizer with stop 14x16, H11mm
Company
Spineup, Inc.
Model
RO0327AB1114X16
Catalog number
RO0327AB1114X16
Device description
Anatomic Trial Sizer with stop 14x16, H11mm
Published
2024-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B806RO0327AB1114X160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth11Millimeter
Height14Millimeter
Width16Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
786-910-0234contact@upgroup.tech

Regulatory Flags#

DUNS number
116999578
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B806ISRO1214L08CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W14xD12xH08ISRO1214L08CA1ISRO1214L08CA12023-10-03
B806ISRO1420L13CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD14xH13ISRO1420L13CA1ISRO1420L13CA12023-10-04
B806ISRO1620A12CA10ROMERO SELF-ANCHORED CERVICAL CAGE, W20xD16xH12ISRO1620A12CA1ISRO1620A12CA12023-10-03
B806ISRO1214A04CB10ROMERO CERVICAL CAGE, W14xD12xH04ISRO1214A04CB1ISRO1214A04CB12023-08-28
B806ISRO1214A05CB10ROMERO CERVICAL CAGE, W14xD12xH05ISRO1214A05CB1ISRO1214A05CB12023-08-28
B806ISRO1214A06CB10ROMERO CERVICAL CAGE, W14xD12xH06ISRO1214A06CB1ISRO1214A06CB12023-08-28
B806ISRO1214A07CB10ROMERO CERVICAL CAGE, W14xD12xH07ISRO1214A07CB1ISRO1214A07CB12023-08-28
B806ISRO1214A08CB10ROMERO CERVICAL CAGE, W14xD12xH08ISRO1214A08CB1ISRO1214A08CB12023-08-28
B806ISRO1214A09CB10ROMERO CERVICAL CAGE, W14xD12xH09ISRO1214A09CB1ISRO1214A09CB12023-08-28
B806ISRO1214A10CB10ROMERO CERVICAL CAGE, W14xD12xH10ISRO1214A10CB1ISRO1214A10CB12023-08-28
B806ISRO1214A11CB10ROMERO CERVICAL CAGE, W14xD12xH11ISRO1214A11CB1ISRO1214A11CB12023-08-28
B806ISRO1214A12CB10ROMERO CERVICAL CAGE, W14xD12xH12ISRO1214A12CB1ISRO1214A12CB12023-08-28
B806ISRO1214A13CB10ROMERO CERVICAL CAGE, W14xD12xH13ISRO1214A13CB1ISRO1214A13CB12023-08-28
B806ISRO1214L04CB10ROMERO CERVICAL CAGE, W14xD12xH04ISRO1214L04CB1ISRO1214L04CB12023-08-24
B806ISRO1214L05CB10ROMERO CERVICAL CAGE, W14xD12xH05ISRO1214L05CB1ISRO1214L05CB12023-08-24
B806ISRO1214L06CB10ROMERO CERVICAL CAGE, W14xD12xH06ISRO1214L06CB1ISRO1214L06CB12023-08-24
B806ISRO1214L07CB10ROMERO CERVICAL CAGE, W14xD12xH07ISRO1214L07CB1ISRO1214L07CB12023-08-24
B806ISRO1214L08CB10ROMERO CERVICAL CAGE, W14xD12xH08ISRO1214L08CB1ISRO1214L08CB12023-08-24
B806ISRO1214L09CB10ROMERO CERVICAL CAGE, W14xD12xH09ISRO1214L09CB1ISRO1214L09CB12023-08-24
B806ISRO1214L10CB10ROMERO CERVICAL CAGE, W14xD12xH10ISRO1214L10CB1ISRO1214L10CB12023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118131782LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
00888118131799LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
07640187463460POYA Medial TemplateBonebridge AGHWT2026-05-22
00888118145321PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00888118145338PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00889024706347OSS RS ROT Hinged Knee Provisional 20MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706354OSS RS ROT Hinged Knee Provisional 22MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706361OSS RS ROT Hinged Knee Provisional 14MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706378OSS RS ROT Hinged Knee Provisional 12MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706385OSS RS ROT Hinged Knee Provisional 16MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706392OSS RS ROT Hinged Knee Provisional 18MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706514REDUCED Z1 STD NECK TRL SZ 10-12Zimmer, Inc.HWT2026-03-19
00889024706521REDUCED Z1 STD NECK TRL SZ 0-9Zimmer, Inc.HWT2026-03-19
04046826472061MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472078MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472085MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
10885862609588VantageExactech, Inc.HWT2026-03-19
10885862648037EquinoxeExactech, Inc.HWT2026-03-19
10885862648044EquinoxeExactech, Inc.HWT2026-03-19
10885862648051EquinoxeExactech, Inc.HWT2026-03-19
10885862648068EquinoxeExactech, Inc.HWT2026-03-19
10885862648075EquinoxeExactech, Inc.HWT2026-03-19
10885862648082EquinoxeExactech, Inc.HWT2026-03-19
10885862659712N/AExactech, Inc.HWT2026-03-19
10885862659729N/AExactech, Inc.HWT2026-03-19
10885862659736N/AExactech, Inc.HWT2026-03-19
10885862659750N/AExactech, Inc.HWT2026-03-19
10885862659767N/AExactech, Inc.HWT2026-03-19
10885862659774N/AExactech, Inc.HWT2026-03-19
10885862659781N/AExactech, Inc.HWT2026-03-19