FDA.reportPublic FDA data

Tailored-H Cervical Standalone System

Primary DI
00810204090154
Brand
Tailored-H Cervical Standalone System
Company
Demetra, Inc.
Model
BCSD-4012
Device description
TAILORED-H VARIABLE SCREW - SELF DRILLING - 4.0x12MM
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222903000Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC2022-11-18OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810204090154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810204090154008102040901548102040901540810204090154

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Regulatory Flags#

DUNS number
119561472
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810204090017Tailored-H Cervical Standalone SystemBCS7-1416-62026-09-30
00810204090024Tailored-H Cervical Standalone SystemBCS7-1416-72026-09-30
00810204090031Tailored-H Cervical Standalone SystemBCS7-1416-82026-09-30
00810204090048Tailored-H Cervical Standalone SystemBCS7-1416-92026-09-30
00810204090055Tailored-H Cervical Standalone SystemBCS7-1416-102026-09-30
00810204090062Tailored-H Cervical Standalone SystemBCS12-1416-62026-09-30
00810204090079Tailored-H Cervical Standalone SystemBCS12-1416-72026-09-30
00810204090086Tailored-H Cervical Standalone SystemBCS12-1416-82026-09-30
00810204090093Tailored-H Cervical Standalone SystemBCS12-1416-92026-09-30
00810204090109Tailored-H Cervical Standalone SystemBCS12-1416-102026-09-30
00810204090116Tailored-H Cervical Standalone SystemBCSD-35122026-09-30
00810204090123Tailored-H Cervical Standalone SystemBCSD-35142026-09-30
00810204090130Tailored-H Cervical Standalone SystemBCSD-35162026-09-30
00810204090147Tailored-H Cervical Standalone SystemBCSD-35182026-09-30
00810204090161Tailored-H Cervical Standalone SystemBCSD-40142026-09-30
00810204090178Tailored-H Cervical Standalone SystemBCSD-40162026-09-30
00810204090185Tailored-H Cervical Standalone SystemBCSD-40182026-09-30
00810204090192Tailored-H Cervical Standalone SystemBCSL-0012026-09-30
00810204090420Tailored-C Cervical Interbody Fusion SystemBC7-1416-52026-09-30
00810204090437Tailored-C Cervical Interbody Fusion SystemBC7-1416-62026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.OVE2026-10-01
00810204090017Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090024Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090031Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090048Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090055Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090062Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090079Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090086Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090093Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090109Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090116Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090123Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090130Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090147Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090161Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090178Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090185Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090192Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810017916108SABER-XA, Expandable Spacer, 34x26mm, 11mm, (6°)ELEVATION SPINE, INC.OVE2026-09-29
00810017916115SABER-XA, Expandable Spacer, 34x26mm, 13mm, (12°)ELEVATION SPINE, INC.OVE2026-09-29
00810017916122SABER-XA, Expandable Spacer, 34x26mm, 16mm, (18°)ELEVATION SPINE, INC.OVE2026-09-29
00810017916177SABER-XA, Expandable Spacer, 37x28mm,11mm, (6°)ELEVATION SPINE, INC.OVE2026-09-29
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
10888857026551CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
10888857026582CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
07613327506518Anchor CStryker CorporationOVE2019-12-18