FDA.reportPublic FDA data

ORTHOMED

Primary DI
B803450300LH0
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 45-0300LH
Device description
"BONE REDUCTION FCPS. 5"" LEFT HAND"
Published
2024-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXDClamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B803450300LH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone holding forcepsA manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
086618626
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8035903160ORTHOMEDOM 59-03162026-07-22
B8038600980ORTHOMEDOM 86-00982026-07-22
B8038600990ORTHOMEDOM 86-00992026-07-22
B803860120L0ORTHOMEDOM 86-0120L2026-07-22
B8038601250ORTHOMEDOM 86-01252026-07-22
B8039018420ORTHOMEDOM 90-18422026-07-22
B8039018430ORTHOMEDOM 90-18432026-07-22
B8039018840ORTHOMEDOM 90-18842026-07-22
B8039030020ORTHOMEDOM 90-30022026-07-22
B803903220010ORTHOMEDOM 90-3220-012026-07-22
B803903220020ORTHOMEDOM 90-3220-022026-07-22
B8039401000ORTHOMEDOM 94-01002026-07-22
B8039601360ORTHOMEDOM 96-01362026-07-22
B8039601370ORTHOMEDOM 96-01372026-07-22
B8039601390ORTHOMEDOM 96-01392026-07-22
B8039601400ORTHOMEDOM 96-01402026-07-22
B803NL97010ORTHOMEDOM NL97012026-07-22
B803NL9701H0ORTHOMEDOM NL9701-H2026-07-22
B803PW12A0ORTHOMEDOM PW-12A2026-07-22
B803PW14G0ORTHOMEDOM PW-14G2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9017971000Surgical DirectSurgical Direct, Inc.HXD2026-08-21
00190776426606MillenniumAvalign Technologies, Inc.HXD2026-08-19
00840277133779Innomed, Inc.INNOMED, INC.HXD2026-08-18
00840277133786Innomed, Inc.INNOMED, INC.HXD2026-08-18
05060624127007CS Mayfield / Doro AdaptorsCARE SURGICAL LIMITEDHXD2026-08-07
00190776405786MillenniumAvalign Technologies, Inc.HXD2026-07-24
04058749047981NAFehling Instruments GmbH & Co. KGHXD2026-07-17
B8034503260ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503660ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503700ORTHOMEDORTHO-MED, INC.HXD2026-07-14
00840277133656Innomed, Inc.INNOMED, INC.HXD2026-05-29
ESAM3840131STOMA®Storz am Mark GmbHHXD2025-04-30
ESAM3841131STOMA®Storz am Mark GmbHHXD2025-04-30
00840314269690gSourceGSOURCE LLCHXD2025-01-15
00840314269591gSourceGSOURCE LLCHXD2024-08-14
10840199539571Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539588Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539595Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539601Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539618Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539625Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539632Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539649Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199535894ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535948Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535955Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535979Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536013Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536020Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536037Aortic ClampKOROS U.S.A., INC.HXD2024-01-31