HALLU LOCK
- Primary DI
- 10381780044260
- Brand
- HALLU LOCK
- Company
- NEWDEAL
- Model
- 290645SND
- Catalog number
- 290645SND
- Device description
- The sterile HALLU Lock plates are available in two different designs (the HALLU Lock S plate and the HALLU Lock C plate) and in different sizes (left/right). They are implanted using Newdeal fixed or variable angle locking system fixation screws and washers. They are both low profile Titanium plates dedicated to the first metatarso-phalangeal arthrodesis. Pre-bending is possible to completely fit the anatomical shape of the joint.
- Published
- 2017-10-09
- 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
Contact Domains#
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 |
|---|---|
| K083154 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780044260 | Primary | GS1 | 0 | |
| M248290645SND1 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780044260 | 10381780044260 |
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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Store in dry place. |
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 536935331
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- No natural rubber latex
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10381780045687 | K-WIRE | 115071ND | 115071ND | 2017-10-09 |
| 10381780045731 | K-WIRE | 115110ND | 115110ND | 2017-10-09 |
| 10381780045755 | K-WIRE | 115111ND | 115111ND | 2017-10-09 |
| 10381780045786 | K-WIRE | 115170ND | 115170ND | 2017-10-09 |
| 10381780045809 | K-WIRE | 115171ND | 115171ND | 2017-10-09 |
| 10381780045847 | K-WIRE | 115316ND | 115316ND | 2017-10-09 |
| 10381780045854 | K-WIRE | 115416ND | 115416ND | 2017-10-09 |
| 10381780041771 | QWIX® | 119932ND | 2017-05-26 | |
| 10381780042099 | Hallu®-FIX | 129930ND | 2017-05-26 | |
| 10381780042136 | Hallu®-FIX | 129935ND | 2017-05-26 | |
| 10381780042266 | ADVANSYS® | 169101ND | 2017-05-26 | |
| 10381780042273 | ADVANSYS® | 169102ND | 2017-05-26 | |
| 10381780042280 | ADVANSYS® | 169104ND | 2017-05-26 | |
| 10381780042327 | ADVANSYS® | 188201ND | 2017-05-26 | |
| 10381780042334 | ADVANSYS® | 188202ND | 2017-05-26 | |
| 10381780042419 | IPP-ON® | 239000ND | 2017-05-26 | |
| 10381780042426 | IPP-ON® | 239001ND | 2017-05-26 | |
| 10381780042778 | PANTA® | 519920ND | 2017-05-26 | |
| 10381780042822 | SURFIX® | SET000ND | 2017-05-26 | |
| 10381780042839 | SURFIX® | SET100ND | 2017-05-26 |
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 |