FDA.reportPublic FDA data

ZESPIN SI Joint Fusion System

Primary DI
00840273312246
Brand
ZESPIN SI Joint Fusion System
Company
Aegis Spine, Inc.
Model
SI01-0502
Catalog number
SI01-0502
Device description
GRAFT IMPACTOR
Published
2022-05-06
Public version status
Update
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
00840273312246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840273312246008402733122468402733122460840273312246

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. 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
00840273311836ZESPIN SI Joint Fusion System1023-6065S1023-6065S2022-05-06
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
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03