ARMAR™ / ARTIS™
- Primary DI
- 08904255305489
- Brand
- ARMAR™ / ARTIS™
- Company
- MERIL HEALTHCARE PRIVATE LIMITED
- Model
- MT-PT0303055R
- Device description
- 2.7mm/3.5mm Posterolateral Distal Humerus Plate, with Lateral Support, Right - The Bone Plate is composed of individually packaged plate designed for internal fixation, stabilization, reconstruction and support of fractured bone fracture. The Bone Plates are thin metal plates manufactured from Titanium-6Aluminium-7Niobium Alloy (TAN) complies with ISO 5832-11/ASTM F1295, titanium grade 4 (TiCP) complies with ASTM F67 / EN ISO 5832-2 and 18Chromium-14Nickel 2.5Molybdenum Stainless Steel (SS 316L & SS316LVM) complies with ASTM F138 and ASTM F139/ EN ISO 5832-1 and are used to reconstruct a bone that has been fractured. They immobilize the bone segments. For severe fractures, bone plates are surgically implanted to hold the bone in place. The plate is affixed with screws to properly align the bone and aid in the healing process.
- Published
- 2026-07-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HRS | Plate, Fixation, Bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K171320 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K171320 | 000 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws | Meril Healthcare Pvt. , Ltd. | 2018-03-08 | HRS |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08904255305489 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08904255305489 | 08904255305489 | 8904255305489 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic fixation plate, non-bioabsorbable | A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. |
Regulatory Flags#
- DUNS number
- 872346811
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- 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 | Catalog | Published |
|---|---|---|---|---|
| 08904255300002 | ARMAR™ / ARTIS™ | MT-PT0804059 | 2026-07-17 | |
| 08904255300019 | ARMAR™ / ARTIS™ | MT-PT0805072 | 2026-07-17 | |
| 08904255300026 | ARMAR™ / ARTIS™ | MT-PT0806085 | 2026-07-17 | |
| 08904255300033 | ARMAR™ / ARTIS™ | MT-PT0807098 | 2026-07-17 | |
| 08904255300040 | ARMAR™ / ARTIS™ | MT-PT0808111 | 2026-07-17 | |
| 08904255300057 | ARMAR™ / ARTIS™ | MT-PT0809124 | 2026-07-17 | |
| 08904255300064 | ARMAR™ / ARTIS™ | MT-PT0810137 | 2026-07-18 | |
| 08904255300071 | ARMAR™ / ARTIS™ | MT-PT0811150 | 2026-07-18 | |
| 08904255300088 | ARMAR™ / ARTIS™ | MT-PT0812163 | 2026-07-18 | |
| 08904255300095 | ARMAR™ / ARTIS™ | MT-PT0813176 | 2026-07-18 | |
| 08904255300101 | ARMAR™ / ARTIS™ | MT-PT0814189 | 2026-07-18 | |
| 08904255300118 | ARMAR™ / ARTIS™ | MT-PT0815202 | 2026-07-18 | |
| 08904255300125 | ARMAR™ / ARTIS™ | MT-PT0816215 | 2026-07-18 | |
| 08904255300132 | ARMAR™ / ARTIS™ | MT-PT0818241 | 2026-07-18 | |
| 08904255300149 | ARMAR™ / ARTIS™ | MT-PT0820267 | 2026-07-18 | |
| 08904255300156 | ARMAR™ / ARTIS™ | MT-PT0822293 | 2026-07-18 | |
| 08904255300163 | ARMAR™ / ARTIS™ | MT-PS0602026 | 2026-07-18 | |
| 08904255300170 | ARMAR™ / ARTIS™ | MT-PS0603038 | 2026-07-18 | |
| 08904255300187 | ARMAR™ / ARTIS™ | MT-PS0604050 | 2026-07-18 | |
| 08904255300194 | ARMAR™ / ARTIS™ | MT-PS0605062 | 2026-07-18 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 08904255300064 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300071 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300088 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300095 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300101 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300118 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300125 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300132 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300149 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300156 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300163 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300170 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300187 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300194 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300200 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300217 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300224 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300231 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300248 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300255 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300262 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300705 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300712 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300729 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300736 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300743 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300750 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300767 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300774 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |
| 08904255300781 | ARMAR™ / ARTIS™ | MERIL HEALTHCARE PRIVATE LIMITED | HRS | 2026-07-18 |