FDA.reportPublic FDA data

ZESPIN SI Joint Fusion System

Primary DI
00840273312239
Brand
ZESPIN SI Joint Fusion System
Company
Aegis Spine, Inc.
Model
SI01-0501
Catalog number
SI01-0501
Device description
BONE GRAFT PACKING BLOCK
Published
2022-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840273312239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840273312239008402733122398402733122390840273312239

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft packing blockA device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
017993061
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
00840273312246ZESPIN SI Joint Fusion SystemSI01-0502SI01-05022022-05-06
00840273320937Paeon Anterior Cervical Plate System6712-17316712-17312023-01-30
00840273320944Paeon Anterior Cervical Plate System6712-17336712-17332023-01-30
00840273320951Paeon Anterior Cervical Plate System6713-17426713-17422023-01-30
00840273320968Paeon Anterior Cervical Plate System6713-17456713-17452023-01-30
00840273320975Elatus Lumbar Plate System5015-14265015-14262023-01-30
00840273320982Elatus Lumbar Plate System5015-15275015-15272023-01-30
00840273320999Elatus Lumbar Plate System5015-16285015-16282023-01-30
00840273321002Elatus Lumbar Plate System5015-18305015-18302023-01-30
00840273321286Paeon Anterior Cervical Plate System6712-1731S6712-1731S2023-01-30
00840273321293Paeon Anterior Cervical Plate System6712-1733S6712-1733S2023-01-30
00840273321309Paeon Anterior Cervical Plate System6713-1742S6713-1742S2023-01-30
00840273321316Paeon Anterior Cervical Plate System6713-1745S6713-1745S2023-01-30
00840273321323Elatus Lumbar Plate System5015-1426S5015-1426S2023-01-30
00840273321330Elatus Lumbar Plate System5015-1527S5015-1527S2023-01-30
00840273321347Elatus Lumbar Plate System5015-1628S5015-1628S2023-01-30
00840273321354Elatus Lumbar Plate System5015-1830S5015-1830S2023-01-30
00840273310976Paeon Posterior Cervical Fixation SystemCS02-0702CS02-07022022-05-03
00840273311003Paeon Posterior Cervical Fixation SystemCS02-0705CS02-07052022-05-03
00840273311010Paeon Posterior Cervical Fixation SystemCS02-0706CS02-07062022-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536085552neon3Ulrich GmbH & Co. KGLXH2026-05-28
M7403030028Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030029Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030030Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030031Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030032Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030033Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030034Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030035Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030036Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030059Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030060Discectomy SetSPINEOLOGY INC.LXH2026-05-28
00810166522816Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522823Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522830Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522847Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522854Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522861Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522878Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00889929072424Matrixx SystemNEXXT SPINE, LLCLXH2026-05-27
07640187918809Straight reamer handleMPS Micro Precision Systems AGLXH2026-05-27
07613327007114ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-25
07613327007558XIA 3Stryker CorporationLXH2019-11-25
07613327007565XIA 3Stryker CorporationLXH2019-11-25
07613327114881XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327121919XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327126273AVS Anchor-C Cervical Cage SystemStryker CorporationLXH2019-11-25
07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25