FDA.reportPublic FDA data

SI-RESTORE

Primary DI
00850073363256
Brand
SI-RESTORE
Company
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
Model
1701-300027
Device description
BONE GRAFT PLUNGER
Published
2025-03-17
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182919000SI-Restore® Sacroiliac Joint Fixation SystemBiofusion Medical2019-01-25OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850073363256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073363256008500733632568500733632560850073363256

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft funnelA device designed to deliver bone graft filling material (autologous, allogeneic, xenogeneic, or synthetic) during an orthopaedic procedure to enable the filling of bone gaps intended to be fused. It is a funnel-shaped device; the funnel being bowl-shaped with the ability to hold back the filling material depending upon the angle of tilt applied by the surgeon, and a long, thin tube that can be inserted into the site to be filled, e.g., a cancellous bone graft being discharged into the posterior disc space of a vertebra. An orthopaedic graft inserter can be pushed down the funnel tube to press the graft material into the site. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
125905168
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850073363683SI-RESTORE1701-5000112025-04-04
00850073363669SI-RESTORE1701-3000572025-03-25
00850073363676SI-RESTORE1701-3000852025-03-25
00850073363140SI-RESTORE1701-3000012025-03-17
00850073363157SI-RESTORE1701-3000032025-03-17
00850073363164SI-RESTORE1701-3000052025-03-17
00850073363171SI-RESTORE1701-3000072025-03-17
00850073363188SI-RESTORE1701-3000092025-03-17
00850073363195SI-RESTORE1701-3000132025-03-17
00850073363201SI-RESTORE1701-3000152025-03-17
00850073363218SI-RESTORE1701-3000172025-03-17
00850073363225SI-RESTORE1701-3000212025-03-17
00850073363232SI-RESTORE1701-3000232025-03-17
00850073363249SI-RESTORE1701-3000252025-03-17
00850073363263SI-RESTORE1701-3000292025-03-17
00850073363270SI-RESTORE1701-3000312025-03-17
00850073363287SI-RESTORE1701-3000332025-03-17
00850073363294SI-RESTORE1701-3000352025-03-17
00850073363300SI-RESTORE1701-3000372025-03-17
00850073363317SI-RESTORE1701-3000392025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
00810055525164NON NAVIGATED STYLET-OBTURATOR ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525188CANNULATED PROBE IMPACTION CAP ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525195CANNULATED PROBE HANDLE ASSEMBLYSi-Bone Inc.LXH2026-10-27
00810055525218GRANITE CANNULATED PROBE SHAFTSi-Bone Inc.LXH2026-10-27
00889024702233OsseoFitZimmer, Inc.LXH2026-10-27
00889024702240OsseoFitZimmer, Inc.LXH2026-10-27
00889024702479OsseoFitZimmer, Inc.LXH2026-10-27
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23