FDA.reportPublic FDA data

Scoliometer

Primary DI
00842430108891
Brand
Scoliometer
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
5280
Catalog number
5280
Published
2019-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTHProtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTHProtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430108891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430108891008424301088918424301088910842430108891

GMDN Terms#

Term, Definition table
TermDefinition
Bone-angle protractorA device intended to be used to measure the angles of bones, e.g., on x-rays or during surgery. It is commonly known as a protractor. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430117312ADANTE DURABLE BODY STRAP, NO HOOK6895-13656895-13652026-04-17
00842430116667ADANTE PELVIC CENTER POSTLESS PAD6895-13066895-13062025-07-04
00842430116735ADANTE ADAPTER, MAI CLARK SOCKET6895-21906895-21902026-03-31
00842430116766 WELL LEG SUPPORT, SHORT5855-838S5855-838S2026-03-31
00842430116742PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
00842430116759PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
10842430116749PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
10842430116756PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
00842430101717TABLE, INSITE684468442020-09-09
00842430107450INSITE TABLE, 230V6844i6844i2020-09-09
00842430107467TABLE, ProFx, 230 VOLT6850i6850i2020-09-09
00842430112102TABLE, ProFx685068502020-09-09
00842430114601TABLE, INSITE, 100V6844J6844J2020-09-08
00842430100017Allegro Imaging Table 120V, 60HZ680068002016-09-13
00842430100024Allegro Imaging Table 220-230V, 50/60HZ6800I6800I2016-09-15
00842430109188PRONECONNECT PROTECTIVE HELMETPC501FHPC501FH2025-08-29
00842430109195PRONECONNECT ADJUSTABLE HELMETPC502AHPC502AH2025-08-29
00842430109201PRONECONNECT COMBO PACK 4L, 3M, 3SPC-COMBOPC-COMBO2025-08-29
00842430109218PRONECONNECT LOW PROFILE MIRRORPC520MPC520M2025-08-29
00842430109225PRONECONNECT ADJUSTABLE MIRRORPC590MPC590M2025-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008411321863743P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321863813P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321863983P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
008411321874943P Hip SystemORTHOPEDIATRICS CORP.HTH2025-06-19
08800017285429BENCOX DA Instruments Hip SystemCorentec Co., LtdHTH2024-01-29
G223WRROGPRO0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHTH2022-12-05
00614950025503ACEACE SURGICAL SUPPLY CO., INC.HTH2019-10-24
00889024038004NAZimmer, Inc.HTH2016-07-27