HALLMARK
GUDID 18257200018345
78MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS
ORTHOFIX INC.
Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable| Primary Device ID | 18257200018345 |
| NIH Device Record Key | ae6eec13-666b-436a-a866-bf4f1ed5b0e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HALLMARK |
| Version Model Number | 62-6784 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200018345 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100614
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
[18257200018345]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-20 |
| Device Publish Date | 2019-03-12 |
On-Brand Devices [HALLMARK]
| 18257200081523 | HALLMARK (62-9020) |
| 18257200081516 | HALLMARK (62-9001) |
| 18257200062249 | SEQUENCE ADJUSTABLE MODULAR BONE DRILL |
| 18257200062171 | 4 LEVEL PLATE TRAY HALLMARK ACPS |
| 18257200062164 | INSTRUMENT CASE HALLMARK ACPS |
| 18257200062157 | PLATE BENDER HALLMARK ACPS |
| 18257200062133 | TOP LOCKING PLATE SCREW DRIVER HOLDER HALLMARK ACPS |
| 18257200062126 | TORQUE LIMITING HANDLE, 1/4 SQ QUICK LOCK HALLMARK ACPS |
| 18257200062119 | TOP LOCKING PLATE SCREW DRIVER HALLMARK ACPS |
| 18257200062102 | BONE SCREW DRIVER/HOLDER HALLMARK ACPS |
| 18257200062089 | SLEEVED BONE AWL ASSEMBLY HALLMARK ACPS |
| 18257200062072 | MODULAR BONE AWL HALLMARK ACPS |
| 18257200062065 | TACK HOLDER ASSY HALLMARK ACPS |
| 18257200062058 | DRILL GUIDE HALLMARK ACPS |
| 18257200018468 | 98MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018451 | 95MM FIVE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018444 | 94MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018437 | 90MM FIVE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018420 | 90MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018413 | 90MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018406 | 86MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018390 | 86MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018383 | 85MM FIVE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018376 | 82MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018369 | 82MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018352 | 80MM FIVE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018345 | 78MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018338 | 78MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018321 | 74MM FOUR LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018314 | 74MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018307 | 72MM FOUR LEVEL CERVICAL PLATE ASSEMBLY |
| 18257200018291 | 70MM FOUR LEVEL CERVICAL PLATE ASSEMBLY |
| 18257200018284 | 70MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018277 | 68MM FOUR LEVEL CERVICAL PLATE ASSEMBLY |
| 18257200018260 | 68MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018253 | 66MM FOUR LEVEL CERVICAL PLATE ASSEMBLY |
| 18257200018246 | 66MM THREE LEVEL CERVICAL PLATE ASSEMBLY, HALLMARK ACPS |
| 18257200018239 | 64MM FOUR LEVEL CERVICAL PLATE ASSEMBLY |
| 18257200018222 | 64mm Three Level Cervical Plate |
| 18257200018215 | 62mm Four Level Cervical Plate |
| 18257200018208 | 62mm Three Level Cervical Plate |
| 18257200018192 | 60mm Three Level Cervical Plate |
| 18257200018185 | 58mm Three Level Cervical Plate |
| 18257200018178 | 56mm Three Level Cervical Plate |
| 18257200018161 | 54mm Three Level Cervical Plate |
| 18257200018154 | 54mm Two Level Cervical Plate |
| 18257200018147 | 52mm Three Level Cervical Plate |
| 18257200018130 | 52mm Two Level Cervical Plate |
| 18257200018123 | 110mm Five Level Cervical Plate |
| 18257200018116 | 50mm Three Level Cervical Plate |
Trademark Results [HALLMARK]
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