FDA.reportPublic FDA data

Tailored-H

Primary DI
00850018366731
Brand
Tailored-H
Company
BESPOKE TECHNOLOGIES, LLC
Model
BCS-002-06
Device description
INSERTER & SCREW GUIDE - 6MM
Published
2025-03-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018366731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018366731008500183667318500183667310850018366731

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
056684302
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018366007Tailored-CBCI-0012025-03-24
00850018366427Tailored-CBCI-1012025-03-24
00850018366724Tailored-HBCS-003-062025-03-24
00850018366748Tailored-HBCS-0012025-03-24
00850018366809Tailored-HBCS-002-072025-03-24
00850018366816Tailored-HBCS-002-082025-03-24
00850018366823Tailored-HBCS-002-092025-03-24
00850018366830Tailored-HBCS-002-102025-03-24
00850018366847Tailored-HBCS-002-112025-03-24
00850018366854Tailored-HBCS-002-122025-03-24
00850018366861Tailored-HBCS-003-072025-03-24
00850018366878Tailored-HBCS-003-082025-03-24
00850018366885Tailored-HBCS-003-092025-03-24
00850018366892Tailored-HBCS-003-102025-03-24
00850018366908Tailored-HBCS-003-112025-03-24
00850018366915Tailored-HBCS-003-122025-03-24
00850018366069Tailored-CBC4-1214-52025-03-21
00850018366076Tailored-CBC4-1214-62025-03-21
00850018366083Tailored-CBC4-1214-72025-03-21
00850018366090Tailored-CBC4-1214-82025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776391560CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391577CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391584CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391591CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391607CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391614CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391621CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391638CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391645CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391652CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391669CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391676CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-09
00190776391553CONDUIT ZERO-P VAAvalign Technologies, Inc.OVE2026-07-08
00810017916450Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916467Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916474Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.OVE2026-07-07
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.OVE2026-06-25
00763000880477|Endoskeleton™ TCS Interbody SystemMEDTRONIC SOFAMOR DANEK, INC.OVE2026-06-22