Identity
- Trade Name
- Osteomesh FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Device Name
- Dimensions: 13 x 8 x 4 x 6 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. FDA UDI
- Model / Reference
- PC51(13,8,4,6) FDA UDI
- Description
- Dimensions: 13 x 8 x 4 x 6 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08885013200546 FDA UDI
- 510(k) Number
- K051093 FDA UDI
- FDA Product Code
- GXP FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 13 Millimeter FDA UDIWidth — 8 Millimeter FDA UDIDepth — 4 Millimeter FDA UDIHeight — 6 Millimeter FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
Osteomesh by Osteopore International Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K051093 also covers:
- Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteomesh — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteoplug — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteoplug — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteoplug — OSTEOPORE INTERNATIONAL PTE. LTD.
- Osteoplug — OSTEOPORE INTERNATIONAL PTE. LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Osteopore International Pte. Ltd.
Sources (1)
- FDA UDI 76983c4e-f64d-4b6b-afa5-ec6bb6a38e3f 37 fields · synced May 29, 2026