FDA.reportPublic FDA data

Osteoplug

Primary DI
08885013201376
Brand
Osteoplug
Company
OSTEOPORE INTERNATIONAL PTE. LTD.
Model
PC22(13,13,4)
Device description
Dimensions: 13 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.
Published
2020-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K051093000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051093000OSTEOPORE PCL SCAFFOLDOsteopore, Inc.2006-03-17GXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885013201376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885013201376088850132013768885013201376

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
Depth0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@osteopore.com

Regulatory Flags#

DUNS number
894834738
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
08885013200393OsteomeshPTSH-039-025-001-P22018-07-19
08885013201031OsteoplugNEBP-1305-P2016-09-26
08885013201048OsteoplugNEBP-1505-P2016-09-26
08885013201130Osteoplug-CCHBP-1305-P2016-09-26
08885013201147Osteoplug-CCHBP-1505-P2016-09-26
08885013201192Osteoplug-CCHBP-0707-S2018-07-19
08885013201307OsteoplugPC23(9,9,4)2023-08-02
08885013201314OsteoplugPC23(10,10,4)2023-08-02
08885013200133OsteomeshPC11(50,50,1.5)2022-09-26
08885013201321OsteoplugPC22(8,8,4)2022-09-26
08885013201338OsteoplugPC22(9,9,4)2022-09-26
08885013200041OsteomeshPC11(25,25,1)2020-08-10
08885013200140OsteomeshPC11(50,50,2)2020-08-10
08885013200195OsteostripPC17(100,3.5,4)2020-08-10
08885013200409OsteostripPC17(100,2,4)2020-08-10
08885013200478OsteostripPC18(60,3.5,4)2020-08-10
08885013200485OsteostripPC18(60,2,4)2020-08-10
08885013200508OsteomeshPC12(39,10,1.25)2020-08-10
08885013200546OsteomeshPC51(13,8,4,6)2020-08-10
08885013200577OsteomeshPC12(39,10,1)2020-08-10

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
08800065231867TnR 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