FDA.reportPublic FDA data

Fusion Biologics

Primary DI
00840124515307
Brand
Fusion Biologics
Company
FUSION ORTHOPEDICS, LLC
Model
CD-BH-1008-S
Catalog number
CD-BH-1008-S
Device description
Bone Harvester Kit 8mm
Published
2025-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124515307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124515307008401245153078401245153070840124515307

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft delivery kitA collection of sterile devices intended to be used to prepare and/or deliver bone graft material during an orthopaedic surgical procedure. It typically includes aspirating/delivery/mixing syringe(s), an adaptor, and a needle/cannula. It allows for the aspiration and/or premixing of bone marrow, autologous blood, plasma, intravenous fluids (IVF), and bone void filler (e.g., allograft, autograft, synthetic bone graft material), and their delivery to the surgical site. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080307067
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124526044FibFixFN-TH-4713FN-TH-47132026-09-25
00840124526051FibFixFN-TH-4713-SFN-TH-4713-S2026-09-25
00840124526068FibFixFN-TH-5713FN-TH-57132026-09-25
00840124526075FibFixFN-TH-5713-SFN-TH-5713-S2026-09-25
00840124516779FibFixTN-FN-9000TN-FN-90002026-04-09
00840124517783FibFixTN-FN-9000-STN-FN-9000-S2026-04-09
00840124521773PolyLock MidfootTN-CA-2501TN-CA-25012025-10-02
00840124521780PolyLock MidfootTN-CA-2004TN-CA-20042025-10-02
00840124521797PolyLock MidfootTN-CA-2003TN-CA-20032025-10-02
00840124521803PolyLock MidfootTN-CA-2002TN-CA-20022025-10-02
00840124521810PolyLock MidfootTN-CA-2001TN-CA-20012025-10-02
00840124521827PolyLock MidfootTN-CA-2503TN-CA-25032025-10-02
00840124521834PolyLock MidfootTN-CA-2502TN-CA-25022025-10-02
00840124521841PolyLock MidfootTN-CA-2504TN-CA-25042025-10-02
00840124525467FibFixTN-FN-9000-ATN-FN-9000-A2026-04-09
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00840124519220IntraLockTN-LL-5861TN-LL-58612025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141040892Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040908Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040915Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040953Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141040977Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047532Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00810141047549Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCLXH2026-10-22
00840314270351gSourceGSOURCE LLCLXH2026-10-22
00840606175234PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606185820PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186506LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186575SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186612SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186643SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186674SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186704SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186735SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606186810SAPPHIRE XSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187091ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187121PrimusSPINAL ELEMENTS, INC.LXH2026-10-22
00840606187640OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189934OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00840606189941OVERWATCHSPINAL ELEMENTS, INC.LXH2026-10-22
00190776436766MillenniumAvalign Technologies, Inc.LXH2026-10-21
07630699705240Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705257Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705264Surgical Manual InstrumentMedacta International SALXH2026-10-21
07630699705271Surgical Manual InstrumentMedacta International SALXH2026-10-21
10840642132786Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-21