FDA UDI
In Commercial Distribution
🇺🇸 United States
Bioplate®
DI: M3848158920
·
Model: 81-5892
·
Bioplate, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Bioplate®
- Primary DI
- M3848158920
- Version / Model
- 81-5892
- Catalog Number
- 81-5892
- Company Name
- Bioplate, Inc.
- Labeler DUNS
- 838734093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-03
- Public Version
- 7
- Public Version Date
- 2025-06-09
- Public Version Status
- Update
- Public Device Record Key
- 3a27035d-8a33-42cf-af91-4d60267d6d3b
Device Description
Straight Plate - Low-Profile - 2 hole - 14 mm (2), Self-Drilling Screw - 4 mm (4) [5 PK]
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
| JEY | Plate, Bone | Dental | 872.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46638 | Craniofacial bone screw, non-bioabsorbable | A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures. | Yes | Active |
| 46642 | Craniofacial fixation plate, non-bioabsorbable, non-customized | A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M3848158921 | HIBCC | 5 | In Commercial Distribution | ||
| Primary | M3848158920 | HIBCC |
Customer Contacts
- Phone
- 888-246-7528
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082757 | 000 |