FDA.reportPublic FDA data

TnR Cranial Implant

Primary DI
08800065231867
Brand
TnR Cranial Implant
Company
T&R BIOFAB CO.,LTD
Model
GF9-151H
Device description
Type A TnR Cranial Implant is a 3D-printed, synthetic, porous, osteoconductive bone void filler made from polycaprolactone (PCL) and beta-tricalcium phosphate (beta-TCP) that degrades and resorbs in vivo. It has an interconnected porous structure.
Published
2026-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXPMethyl Methacrylate For Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251959000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251959000TnR Cranial ImplantT&R BIOFAB CO., Ltd.2026-07-30GXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800065231867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800065231867088000652318678800065231867

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Length0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
689846880
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
true
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
08800065231270TnR Cranial ImplantGF3-15332026-08-24
08800065231287TnR Cranial ImplantEV-07212026-08-24
08800065231812TnR Cranial ImplantGF4-15442026-08-24
08800065231829TnR Cranial ImplantGF5-15552026-08-24
08800065231836TnR Cranial ImplantGF6-15672026-08-24
08800065231843TnR Cranial ImplantGF7-15782026-08-24
08800065231850TnR Cranial ImplantGF8-15892026-08-24
08800065231874TnR Cranial ImplantGF3-24332026-08-24
08800065231881TnR Cranial ImplantGF4-24442026-08-24
08800065231898TnR Cranial ImplantGF5-24552026-08-24
08800065231904TnR Cranial ImplantGF6-24672026-08-24
08800065231911TnR Cranial ImplantGF7-24782026-08-24
08800065231928TnR Cranial ImplantGF8-24892026-08-24
08800065231935TnR Cranial ImplantGF9-241H2026-08-24
08800065231942TnR Cranial ImplantEV-08222026-08-24
08800065231959TnR Cranial ImplantEV-09232026-08-24
08800065231966TnR Cranial ImplantEV-10242026-08-24
08800065231973TnR Cranial ImplantEV-11252026-08-24
08800065231980TnR Cranial ImplantEV-12262026-08-24
08800065231997TnR Cranial ImplantEV-13272026-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800065231270TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231287TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231812TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231829TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231836TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231843TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231850TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231874TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231881TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231898TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231904TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231911TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231928TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231935TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231942TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231959TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231966TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231973TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231980TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231997TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232000TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232017TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232024TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232031TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232048TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.GXP2026-06-05
00850391007245Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
08885013201307OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
08885013201314OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02