FDA.reportPublic FDA data

Solar™ Interbody Fusion System

Primary DI
00842048181910
Brand
Solar™ Interbody Fusion System
Company
DEGEN MEDICAL, INC.
Model
12-89M
Catalog number
12-89M
Device description
Modular Impactor Head
Published
2024-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00842048181910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842048181910008420481819108420481819100842048181910

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)240-7838customerservice@degenmedical.com

Regulatory Flags#

DUNS number
078812602
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842048154976Solar™ Interbody Fusion System12-28M12-28M2024-10-07
00842048182276DeGen Standard Instrumentation97-68M97-68M2025-03-10
00842048150343Solar™ Interbody Fusion System12-14M12-14M2023-07-15
00842048152996Latitude-C Cervical Interbody Spacer System03-03M03-03M2022-08-22
00842048137559Impulse Interbody Spacer System07-06M07-06M2021-12-22
00842048182726Latitude-C AM™ Cervical Interbody Fusion System0306-161405L040306-161405L042025-11-24
00842048182733Latitude-C AM™ Cervical Interbody Fusion System0306-161406L040306-161406L042025-11-24
00842048182740Latitude-C AM™ Cervical Interbody Fusion System0306-161407L040306-161407L042025-11-24
00842048182757Latitude-C AM™ Cervical Interbody Fusion System0306-161408L040306-161408L042025-11-24
00842048182764Latitude-C AM™ Cervical Interbody Fusion System0306-161409L040306-161409L042025-11-24
00842048182771Latitude-C AM™ Cervical Interbody Fusion System0306-161410L040306-161410L042025-11-24
00842048182788Latitude-C AM™ Cervical Interbody Fusion System0306-161411L040306-161411L042025-11-24
00842048182795Latitude-C AM™ Cervical Interbody Fusion System0306-161412L040306-161412L042025-11-24
00842048182801Latitude-C AM™ Cervical Interbody Fusion System0306-161413L040306-161413L042025-11-24
00842048182818Latitude-C AM™ Cervical Interbody Fusion System0306-161414L040306-161414L042025-11-24
00842048182979Latitude-C AM™ Cervical Interbody Fusion System0306-181410L040306-181410L042025-11-24
00842048182986Latitude-C AM™ Cervical Interbody Fusion System0306-181411L040306-181411L042025-11-24
00842048182993Latitude-C AM™ Cervical Interbody Fusion System0306-181412L040306-181412L042025-11-24
00842048183006Latitude-C AM™ Cervical Interbody Fusion System0306-181413L040306-181413L042025-11-24
00842048183013Latitude-C AM™ Cervical Interbody Fusion System0306-181414L040306-181414L042025-11-24

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