Primary Device ID | 00843210143484 |
NIH Device Record Key | 7c4ed759-bd8c-43db-9e08-c02722f858b2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Indy |
Version Model Number | 1020-42301619 |
Company DUNS | 078331322 |
Company Name | Altus Spine, LLC |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(610)355-4156 |
Info@altus-spine.com |
Angle | 16 degree |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843210143484 [Primary] |
MAX | Intervertebral fusion device with bone graft, lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00843210143484]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2019-10-31 |
00843210147338 | T10 Screwdriver, AO Male Connection |
00843210147321 | T15 Self-Retaining Screwdriver |
00843210147314 | Ø4.2mm Tap |
00843210147284 | Inserter DTS Guide, 20mm H |
00843210147277 | Inserter DTS Guide, 19mm H |
00843210147260 | Inserter DTS Guide, 18mm H |
00843210147253 | Inserter DTS Guide, 17mm H |
00843210147246 | Inserter DTS Guide, 16mm H |
00843210147239 | Inserter DTS Guide, 15mm H |
00843210147222 | Inserter DTS Guide, 14mm H |
00843210147215 | Inserter DTS Guide, 13mm H |
00843210147208 | Inserter DTS Guide, 12mm H |
00843210147192 | Inserter DTS Guide, 11mm H |
00843210147185 | Inserter Guide |
00843210147178 | Implant Inserter |
00843210147048 | U-Joint 4.2mm Tap |
00843210143866 | Tamp, Indy ALIF |
00843210143828 | Graft Packing Block Indy ALIF |
00843210143583 | 19mm H, 12° Distractor |
00843210143576 | 17mm H, 12° Distractor |
00843210143569 | 15mm H, 12° Distractor |
00843210143552 | 13mm H, 12° Distractor |
00843210143545 | 9mm H, 12° Distractor |
00843210143538 | 42mm x 30mm, 25°, 19mm Trial |
00843210143521 | 42mm x 30mm, 25°, 17mm Trial |
00843210143514 | 42mm x 30mm, 20°, 19mm Trial |
00843210143507 | 42mm x 30mm, 20°, 17mm Trial |
00843210143491 | 42mm x 30mm, 20°, 15mm Trial |
00843210143484 | 42mm x 30mm, 16°, 19mm Trial |
00843210143477 | 42mm x 30mm, 16°, 17mm Trial |
00843210143460 | 42mm x 30mm, 16°, 15mm Trial |
00843210143453 | 42mm x 30mm, 16°, 13mm Trial |
00843210143446 | 42mm x 30mm, 12°, 19mm Trial |
00843210143439 | 42mm x 30mm, 12°, 17mm Trial |
00843210143422 | 42mm x 30mm, 12°, 15mm Trial |
00843210143415 | 42mm x 30mm, 12°, 13mm Trial |
00843210143408 | 42mm x 30mm, 12°, 11mm Trial |
00843210143392 | 42mm x 30mm, 8°, 19mm Trial |
00843210143385 | 42mm x 30mm, 8°, 17mm Trial |
00843210143378 | 42mm x 30mm, 8°, 15mm Trial |
00843210143361 | 42mm x 30mm, 8°, 13mm Trial |
00843210143354 | 42mm x 30mm, 8°, 11mm Trial |
00843210143347 | 38mm x 27mm, 25°, 19mm Trial |
00843210142715 | 32mm x 24mm, 8°, 19mm Trial |
00843210142708 | 32mm x 24mm, 8°, 17mm Trial |
00843210139029 | 32mm x 24mm, 8°, 12mm Ti Spacer - Brickyard ALIF System |
00843210139012 | 32mm x 24mm, 8°, 10mm Ti Spacer - Brickyard ALIF System |
00843210138473 | 32mm x 24mm, 16°, 11mm Ti Spacer |
00843210138466 | 32mm x 24mm, 12°, 19mm Ti Spacer |
00843210138459 | 32mm x 24mm, 12°, 17mm Ti Spacer |
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Tispr, Inc. 2022-09-13 |
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Reynaldo Garza 2020-10-20 |
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