LCP
- Primary DI
- H67902112526S0
- Brand
- LCP
- Company
- Synthes GmbH
- Model
- 02.112.526S
- Catalog number
- 02112526S
- Device description
- 3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/12H/RT/213MM-STER
- Published
- 2015-09-14
- 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#
xx.xxProduct Codes#
| Code | Name |
|---|---|
| HRS | PLATE, FIXATION, BONE |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K013248 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10886982034649 | Primary | GS1 | 0 | |
| H67902112526S0 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10886982034649 | 10886982034649 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic fixation plate, non-bioabsorbable, sterile | A sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(800)255-2500 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 486711679
- 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
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10887587078540 | NA | SD03.501.442 | SD03501442 | 2026-07-29 |
| 10886982362179 | NA | SD03.043.006 | SD03043006 | 2026-07-24 |
| 10887587078557 | NA | SD03.503.067 | SD03503067 | 2026-07-24 |
| 10887587078564 | NA | SD03.503.072 | SD03503072 | 2026-07-24 |
| 10705034712307 | NA | 03.604.002 | 03604002 | 2016-12-31 |
| 10705034712802 | NA | 03.606.011 | 03606011 | 2016-12-31 |
| 10705034714592 | NA | 03.613.012 | 03613012 | 2016-12-31 |
| 10705034767819 | VentroFix | 304.834 | 304834 | 2016-12-31 |
| 10705034768939 | NA | 314.064 | 314064 | 2016-12-31 |
| 10705034768960 | Click'X | 314.067 | 314067 | 2016-12-31 |
| 10705034768977 | Click'X | 314.068 | 314068 | 2016-12-31 |
| 10705034768984 | Click'X | 314.069 | 314069 | 2016-12-31 |
| 10705034769646 | NA | 328.026 | 328026 | 2016-12-31 |
| 10705034772608 | NA | 388.364 | 388364 | 2016-12-31 |
| 10705034775401 | NA | 389.288 | 389288 | 2016-12-31 |
| 10705034777375 | NA | 394.585 | 394585 | 2016-12-31 |
| 20705034764051 | NA | 292.020 | 292020 | 2019-08-29 |
| 00863176000317 | FIBULINK | FGS-1100 | FGS1100 | 2020-03-26 |
| 00863176000324 | FIBULINK | FGS-1300 | FGS1300 | 2020-03-26 |
| 00863176000300 | FIBULINK | FGS-1000 | FGS1000 | 2017-06-08 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07899258606637 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606644 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606651 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606668 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606675 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606682 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606699 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606705 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606712 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606729 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606736 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606743 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606750 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606767 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606774 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606781 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606798 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606804 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606811 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606828 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606835 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606842 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606859 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606866 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606873 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606880 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606897 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606903 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258606910 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |
| 07899258609775 | Versalock Proximal Tibial Plating System | GM DOS REIS INDUSTRIA E COMERCIO LTDA | HRS | 2026-07-30 |