FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8035506760
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 55-0676
Device description
ENDO.BONE TAMP 17" 0.38" DIAMETER
Published
2026-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HXGTamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8035506760PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
086618626
Device count
1
DM exempt
false
Premarket exempt
true
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
B8035202680ORTHOMEDOM 52-02682026-06-26
B803PS0099100A0ORTHOMEDOM PS00.991-00A2026-06-26
B803PS00991080ORTHOMEDOM PS00 991-082026-06-26
B803PS0099108A0ORTHOMEDOM PS00 991-08A2026-06-26
B803PS00991090ORTHOMEDOM PS00 991-092026-06-26
B803PS0099109A0ORTHOMEDOM PS00 991-09A2026-06-26
B803PS00991100ORTHOMEDOM PS00 991-102026-06-26
B803PS0099110A0ORTHOMEDOM PS00 991-10A2026-06-26
B803PS0395900ORTHOMEDOM PS03.959-02026-06-26
B803PS03959000ORTHOMEDOM PS03.959-002026-06-26
B803PS039590000ORTHOMEDOM PS03.959-0002026-06-26
B803PS0395910ORTHOMEDOM PS03.959-12026-06-26
B803PS0395920ORTHOMEDOM PS03.959-22026-06-26
B803PS0395930ORTHOMEDOM PS03.959-32026-06-26
B803PS0395950ORTHOMEDOM PS03.959-52026-06-26
B803PS0395960ORTHOMEDOM PS03.959-62026-06-26
B803PS0595940ORTHOMEDOM PS03.959-42026-06-26
B803NL97020450ORTHOMEDOM NL9702-0452026-06-25
B803PS00991010ORTHOMEDOM PS00 991-012026-06-25
B803PS0099101A0ORTHOMEDOM PS00 991-01A2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150076178Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2026-06-05
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHXG2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHXG2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHXG2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHXG2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHXG2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHXG2025-12-17
08800038029323SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
00841732142206GENERIC Surgical InstrumentsCTL Medical CorporationHXG2025-03-31
00841732166950GENERIC Surgical InstrumentsCTL Medical CorporationHXG2024-11-01
08800038058262SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058279SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058286SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058293SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058309SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25