FDA.reportPublic FDA data

Schaerer Medical USA

Primary DI
00810101300103
Brand
Schaerer Medical USA
Company
Schaerer Medical Usa, Inc.
Model
10825
Device description
TIBIA EXTENDER
Published
2022-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEBTable, Surgical With Orthopedic Accessories, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEBTable, Surgical With Orthopedic Accessories, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810101300103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810101300103008101013001038101013001030810101300103

GMDN Terms#

Term, Definition table
TermDefinition
Surgical counter-traction postA cylindrical rod designed to be attached to an operating table or extension device to function as a support to counter the pulling of the traction being applied to a patient's body part (e.g., leg, pelvis) during an orthopaedic surgical procedure (e.g., hip arthroplasty, pelvic reconstruction); it is typically placed against the perineal region [referred to as perineal post] or leg bones (e.g., femur, tibia). It is available in various diameters and lengths and is typically padded. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-755-6381customerservice@schaerermedicalusa.com

Regulatory Flags#

DUNS number
092820703
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810101300261Schaerer Medical USA71077710772022-09-16
10810101300506Schaerer Medical USA10940109402022-09-16
10810101300551Schaerer Medical USA10820108202022-09-16
00810101300080Schaerer Medical USA10823108232022-09-16
00810101300127Schaerer Medical USA10830108302022-09-16
00810101300141Schaerer Medical USA10908109082022-09-16
00810101300189Schaerer Medical USA22111221112022-09-16
00810101300202Schaerer Medical USA529-0715-00529-0715-002022-09-16
00810101300318Schaerer Medical USA73002730022022-09-16
00810101300356Schaerer Medical USA73013730132022-09-16
00810101300387Schaerer Medical USA73020730202022-09-16
00810101300592Schaerer Medical USA528-0128-00528-0128-002022-09-16
00810101300646Schaerer Medical USA528-0134-00528-0134-002022-09-16
00810101300653Schaerer Medical USA528-0134-03528-0134-032022-09-16
00810101300721Schaerer Medical USA528-0150-00528-0150-002022-09-16
00810101300738Schaerer Medical USA528-0150-03528-0150-032022-09-16
00810101300745Schaerer Medical USA528-0151-00528-0151-002022-09-16
00810101300790Schaerer Medical USA528-0162-00528-0162-002022-09-16
00810101300820Schaerer Medical USA528-0213-03528-0213-032022-09-16
00810101300899Schaerer Medical USA6960-36960-32022-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536822543Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822550Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822567Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822574Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822581Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822598Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822604Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822611Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822628Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822635Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822642Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
04251732800383X-Ray Top Seat section PST 500Jörg & Sohn GmbHJEB2026-05-18
04251732800406X-Ray Top Back section PST 500 UJörg & Sohn GmbHJEB2026-05-18
04251732800413Cart for X-Ray TopsJörg & Sohn GmbHJEB2026-05-18
04251732800420Pad leg section light high H GJörg & Sohn GmbHJEB2026-05-18
04251732800437Clamshell Armboard PadJörg & Sohn GmbHJEB2026-05-18
00190776418670MillenniumAvalign Technologies, Inc.JEB2026-04-09
04251732800338X-Ray Top Head sectionJörg & Sohn GmbHJEB2025-06-26
04251732800345X-Ray Top Back section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800352X-Ray Top Seat section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800369X-Ray Top Universal sectionJörg & Sohn GmbHJEB2025-06-26
04251732800376X-Ray Top Leg section one partJörg & Sohn GmbHJEB2025-06-26
G611BIO110210Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110220Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110230Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110240Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024B0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024C0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110310Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110320Alliant BiotechMEDISURGE LLCJEB2024-08-16