FDA.reportPublic FDA data

ZESPIN SI Joint Fusion System

Primary DI
00840273321682
Brand
ZESPIN SI Joint Fusion System
Company
Aegis Spine, Inc.
Model
SI01-0114
Catalog number
SI01-0114
Device description
1st Dilator
Published
2023-01-31
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
00840273321682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840273321682008402733216828402733216820840273321682

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula dilatorA hollow dilator with a tapered distal end intended to enable the gentle insertion of a larger laparoscopic access cannula, necessary when significantly increasing the working access port's lumen, e.g., from 10 to 20 mm diameter. It is commonly used in minimally-invasive laparoscopic procedures. The dilator is entered over a guide rod, forcing a larger opening as the skin is pressed aside, thereby reducing the possible degree of damage. 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
Manufacturing date on label
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
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

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