FDA.reportPublic FDA data

Tailored-H Cervical Standalone System

Primary DI
00810204090086
Brand
Tailored-H Cervical Standalone System
Company
Demetra, Inc.
Model
BCS12-1416-8
Device description
ANTERIOR CERVICAL 3DTI IMPLANT 14x16x8MM - 12°
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
00810204090086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810204090086008102040900868102040900860810204090086

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

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
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
00810204090154Tailored-H Cervical Standalone SystemBCSD-40122026-09-30
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
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
00810204090154Tailored-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