FDA.reportPublic FDA data

ZESPIN SI Joint Fusion System

Primary DI
00840273311836
Brand
ZESPIN SI Joint Fusion System
Company
Aegis Spine, Inc.
Model
1023-6065S
Catalog number
1023-6065S
Device description
Locking Screw Ø6x65mm
Published
2022-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210035000ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate SystemAegis Spine2021-02-16OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840273311836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840273311836008402733118368402733118360840273311836

GMDN Terms#

Term, Definition table
TermDefinition
Physiological pressure monitor calibrator/cableA device intended to provide a reference signal to a pressure monitor (e.g., blood pressure monitor) for: 1) signal integrity/accuracy assessment; and/or 2) standardization of readings of physiological pressure signals [e.g., intracranial pressure (ICP), compartmental pressure]; it is not intended to imitate the signals the monitoring device receives during patient monitoring (i.e., not an electronic-signal simulator). It consists of an electronic or fibreoptic cable or small unit with input and output cables to make electrical or optical connections between a catheter connection cable and the patient monitor. This is a reusable device.

Regulatory Flags#

DUNS number
017993061
Device count
1
DM exempt
false
Premarket exempt
false
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
false

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
M719GSIX1270Sacroiliac Joint Fusion SystemGenesys Orthopedics Systems LLCOUR2026-10-19
B387T5II51300SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
B387T5II51310SiJoin T5 TitaniumVGI MEDICAL, LLCOUR2026-10-09
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOUR2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOUR2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOUR2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOUR2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOUR2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOUR2026-09-25
M719GSIX1210TiLockGenesys Orthopedics Systems LLCOUR2026-08-18
M719G120050SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120060SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120070SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120080SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120090SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120100SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120110SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120120SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120130SIros-XGenesys Orthopedics Systems LLCOUR2026-08-17
M719G120000SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120010SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120020SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120030SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719G120040SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GSIX1260SIros-XGenesys Orthopedics Systems LLCOUR2026-08-03
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOUR2026-07-23
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-07-17
18257200140084Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200140091Firebird SI FusionOrthofix US LLCOUR2026-07-17
18257200143368Firebird SI FusionOrthofix US LLCOUR2026-07-17