Bone Plug
- Primary DI
- 07613153768371
- Brand
- Bone Plug
- Company
- Howmedica Osteonics Corp.
- Model
- B008-0215
- Catalog number
- B008-0215
- Device description
- Sized Cement Plug
- Published
- 2015-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| LTO | SPACER, CEMENT |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LTO | Spacer, Cement | Orthopedic | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K926216 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07613153768371 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07613153768371 | 07613153768371 | 7613153768371 |
GMDN Terms#
| Term | Definition |
|---|---|
| Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile | A sterile, non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs, e.g., straight or tapered, hollow with a fenestrated surface, and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and is not intended for spinal indication. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 058311945
- Device count
- 1
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07613327036503 | Triathlon | 5585-C-016 | 5585-C-016 | 2015-09-24 |
| 07613327036510 | Triathlon | 5585-C-020 | 5585-C-020 | 2015-09-24 |
| 07613327036527 | Triathlon | 5585-C-025 | 5585-C-025 | 2015-09-24 |
| 07613327036534 | Triathlon | 5585-C-030 | 5585-C-030 | 2015-09-24 |
| 07613327036541 | Triathlon | 5585-C-035 | 5585-C-035 | 2015-09-24 |
| 07613327036558 | Triathlon | 5585-C-040 | 5585-C-040 | 2015-09-24 |
| 07613327036565 | Triathlon | 5585-C-045 | 5585-C-045 | 2015-09-24 |
| 07613327036572 | Triathlon | 5585-C-050 | 5585-C-050 | 2015-09-24 |
| 07613327036589 | Triathlon | 5585-C-055 | 5585-C-055 | 2015-09-24 |
| 07613327036596 | Triathlon | 5585-C-060 | 5585-C-060 | 2015-09-24 |
| 07613327041071 | Triathlon | 5520-M-100 | 5520-M-100 | 2015-09-24 |
| 07613327041095 | Triathlon | 5520-M-200 | 5520-M-200 | 2015-09-24 |
| 07613327041101 | Triathlon | 5520-M-300 | 5520-M-300 | 2015-09-24 |
| 07613327041118 | Triathlon | 5520-M-400 | 5520-M-400 | 2015-09-24 |
| 07613327041125 | Triathlon | 5520-M-500 | 5520-M-500 | 2015-09-24 |
| 07613327041132 | Triathlon | 5520-M-600 | 5520-M-600 | 2015-09-24 |
| 07613327041149 | Triathlon | 5520-M-700 | 5520-M-700 | 2015-09-24 |
| 07613327041156 | Triathlon | 5520-M-800 | 5520-M-800 | 2015-09-24 |
| 07613327041392 | Triathlon | 5527-B-100 | 5527-B-100 | 2015-09-24 |
| 07613327041408 | Triathlon | 5527-B-300 | 5527-B-300 | 2015-09-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04546540007896 | Bone Plug | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 04546540007902 | Bone Plug | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 04546540007919 | Bone Plug | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 04546540007926 | Bone Plug | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 04546540007933 | Bone Plug | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 04546540007940 | Bone Plug | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 04546540007957 | Bone Plug | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 07613327013580 | Omnifit | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 07613327013597 | Omnifit | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 07613327013603 | Omnifit | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 07613327013610 | Omnifit | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 07613327013627 | Omnifit | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 07613327013634 | Omnifit | Howmedica Osteonics Corp. | LTO | 2015-09-24 |
| 07613327013641 | Omnifit | Howmedica Osteonics Corp. | LTO | 2015-09-24 |