ALLY™ Bone Screw-L 10mm PD-32-601
GUDID 10852776006307
The bone screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Spinal bone screw, non-bioabsorbable| Primary Device ID | 10852776006307 |
| NIH Device Record Key | 93e9b764-d96c-442a-8a55-d124952401da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALLY™ Bone Screw-L 10mm |
| Version Model Number | PD-32-601 |
| Catalog Number | PD-32-601 |
| Company DUNS | 969820245 |
| Company Name | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852776006300 [Primary] |
| GS1 | 10852776006307 [Package] Contains: 00852776006300 Package: Box [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121713
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10852776006307]
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Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2016-09-27 |
Devices Manufactured by PROVIDENCE MEDICAL TECHNOLOGY, INC.
| 00852776006447 - CAVUX CERVICAL CAGE-X, 5MM | 2024-11-21 CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufac |
| 00852776006553 - ALLY Bone Screw-LX | 2024-11-21 The ALLY Bone Screw-LX is intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fr |
| 00852776006560 - CAVUX Cage-LX, 4mm | 2024-11-21 The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine |
| 00852776006584 - CORUS Spinal System-LX | 2024-11-21 CORUS™ Spinal System-LX is a sterile-packaged set of instruments for joint access, bone preparation, implant delivery, and bon |
| 00852776006591 - CAVUX Facet Fixation System, 4mm | 2024-11-21 CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX |
| 00852776006607 - CAVUX Facet Fixation System, 5mm | 2024-11-21 CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX |
| 00852776006638 - CORUS Navigation Access System | 2024-11-21 The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal Sys |
| 00852776006492 - CAVUX Cervical Cage-X | 2024-11-01 |
Trademark Results [ALLY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALLY 98848840 not registered Live/Pending |
ZHONG SHAN SHI ZHONG MENG SHANG MAO CO., LTD. 2024-11-12 |
 ALLY 98579329 not registered Live/Pending |
CHAMPIONX LLC 2024-05-31 |
 ALLY 98519891 not registered Live/Pending |
OFS Brands Inc. 2024-04-25 |
 ALLY 98287819 not registered Live/Pending |
California Recovery Center Labs, LLC 2023-11-28 |
 ALLY 97896089 not registered Live/Pending |
Intercon Chemical Company 2023-04-19 |
 ALLY 97831054 not registered Live/Pending |
ALLY HOME CARE, LLC 2023-03-09 |
 ALLY 97782558 not registered Live/Pending |
Consumer Cellular, Inc. 2023-02-06 |
 ALLY 97704068 not registered Live/Pending |
Guy & O'Neill, Inc. 2022-12-05 |
 ALLY 97585293 not registered Live/Pending |
Avia Vascular, LLC 2022-09-09 |
 ALLY 97495703 not registered Live/Pending |
Zhongshan Zhongmeng Trading Co., Ltd. 2022-07-08 |
 ALLY 90894560 not registered Live/Pending |
Seqirus Inc. 2021-08-20 |
 ALLY 90296489 not registered Live/Pending |
Ally Financial Inc 2020-11-03 |
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