FDA.reportPublic FDA data

SI-RESTORE

Primary DI
00850073363348
Brand
SI-RESTORE
Company
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
Model
1701-300045
Device description
STEINMANN PIN HOLDER
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
00850073363348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073363348008500733633488500733633480850073363348

GMDN Terms#

Term, Definition table
TermDefinition
Wire holding/twisting forcepsA surgical instrument with specially designed sturdy blades used to grip, tighten and/or twist wires that are being applied to the patient during a surgical intervention. It typically has a scissors-like design with ring handles, is made of high-grade stainless steel and may be self-retaining. It is available in various sizes and the working end can have a variety of jaw designs, e.g., typically short and broad with carbide inserts, but some may be long with side protruding posts around which the loose end of the wire are secured to provide greater grip. The blades/handles are typically strong in profile. 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
00850073363256SI-RESTORE1701-3000272025-03-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534930Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17