FDA.reportPublic FDA data

SI-RESTORE

Primary DI
00850073363225
Brand
SI-RESTORE
Company
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
Model
1701-300021
Device description
14MM FIXED GUIDE
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

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
00850073363225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073363225008500733632258500733632250850073363225

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
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
00850073363317SI-RESTORE1701-3000392025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731153128ARTEMIS FUZEVILEX LLCFZX2026-07-22
00888118147226LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147233LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147240LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147257LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147264LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147271LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147714LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147721LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147738LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147745LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
18257200131198Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131204Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131235Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131334Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200163625PILLAR SA TiOrthofix US LLCFZX2026-07-17
00190446972020Generic InstrumentTrilliant Surgical, LLCFZX2026-07-16
00190446972037Generic InstrumentTrilliant Surgical, LLCFZX2026-07-16
G079PDG2000Advantage-C Ti3D, Cervical InterbodyIntelivation, LLCFZX2026-07-10
M697X07901121Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FZX2026-07-08
00190446948063Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948186Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948445Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948452Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
09421038412237KA Femoral Alignment GuideENZTEC LIMITEDFZX2026-06-24
09421038412244KA Femoral Alignment Guide - Medial PaddleENZTEC LIMITEDFZX2026-06-24
09421038412251KA Femoral Alignment Guide - Lateral PaddleENZTEC LIMITEDFZX2026-06-24
09421038412268KA Femoral Alignment Guide - FanENZTEC LIMITEDFZX2026-06-24