FDA.reportPublic FDA data

SI-RESTORE

Primary DI
00850073363195
Brand
SI-RESTORE
Company
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
Model
1701-300013
Device description
IMPLANT SIZER
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
HTJGauge, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

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
00850073363195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073363195008500733631958500733631950850073363195

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. 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
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
00850073363317SI-RESTORE1701-3000392025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982345455VOLTSynthes GmbHHTJ2026-09-25
00840606191609Overwatch PCFSPINAL ELEMENTS, INC.HTJ2026-07-31
03700569674250Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
03700569674274Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
00842188130311Tools - ScrewsTrimed, INC.HTJ2026-07-22
06974940307243endophixSuzhou Endophix Co., Ltd.HTJ2026-06-23
08809513720045SAEHAN Hydraulic Pinch GaugeSaehan CorporationHTJ2026-05-18
08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
08800322750001AnyPlus®GS Medical Co., Ltd.HTJ2026-04-21
10850070500484Cannulated Depth Guage CURVAFIX, INC.HTJ2025-10-22
00810135963404ImpactNVision Biomedical Technologies, Inc.HTJ2025-09-24
05055662971057ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHTJ2025-08-15
08800071006862Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
08809539690667Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
10840199512703Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10840199513670Multi Level Black Belt Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10885862573483EPICExactech, Inc.HTJ2024-01-08
B56251300MDG000G10WishBone Plate & Screw SystemWishbone Medical, Inc.HTJ2024-01-01
07708604560472SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHTJ2023-01-18
08055727374561DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
08055727374578DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
10603295550273INHANCEDEPUY (IRELAND)HTJ2022-12-09
10855068008607Implant Selection DeviceCURVAFIX, INC.HTJ2022-12-05
B56251300SDG000G10WishBone Plate & Screw SystemWishbone Medical, Inc.HTJ2022-07-18
10855068008331Implant Selection DeviceCURVAFIX, INC.HTJ2021-12-02
08800089415298INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089415328INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089417230INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089418350INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089418374INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18