Zodiac
GUDID 00844856062399
FIXED BRIDGE, 16mm
ALPHATEC SPINE, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00844856062399 |
| NIH Device Record Key | cc149f23-cddc-4c7c-b3c7-64302313278d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zodiac |
| Version Model Number | 11-2516 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 |
Customer Support Contacts
Device Dimensions
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
| Length | 16 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844856062399 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100685
FDA Product Code
| MNH | Orthosis, spondylolisthesis spinal fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
[00844856062399]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-01 |
| Device Publish Date | 2020-06-23 |
On-Brand Devices [Zodiac]
| 00844856063730 | TI 7.5 mm Cannulated High Top Polyaxial Screw ASM, 60 mm Long |
| 00844856063723 | TI 7.5 mm Cannulated High Top Polyaxial Screw ASM, 55 mm Long |
| 00844856063716 | TI 6.5 mm Cannulated High Top Polyaxial Screw ASM, 60 mm Long |
| 00844856063709 | TI 6.5 mm Cannulated High Top Polyaxial Screw ASM, 55 mm Long |
| 00844856063693 | TI 5.5 mm Cannulated High Top Polyaxial Screw ASM, 60 mm Long |
| 00844856063686 | TI 5.5 mm Cannulated High Top Polyaxial Screw ASM, 55 mm Long |
| 00844856063679 | TI 4.5 mm Cannulated High Top Polyaxial Screw ASM, 60 mm Long |
| 00844856063662 | TI 4.5 mm Cannulated High Top Polyaxial Screw ASM, 55 mm Long |
| 00844856063655 | TI 4.5 mm Cannulated High Top Polyaxial Screw ASM, 50 mm Long |
| 00844856043688 | Set Screw, Hexalobe, Titanium |
| 00844856005686 | TI 7.5 mm Cannulated High Top Polyaxial Screw ASM, 50 mm Long |
| 00844856005679 | TI 7.5 mm Cannulated High Top Polyaxial Screw ASM, 45 mm Long |
| 00844856005662 | TI 7.5 mm Cannulated High Top Polyaxial Screw ASM, 40 mm Long |
| 00844856005655 | TI 7.5 mm Cannulated High Top Polyaxial Screw ASM, 35 mm Long |
| 00844856005648 | TI 7.5 mm Cannulated High Top Polyaxial Screw ASM, 30 mm Long |
| 00844856005631 | TI 6.5 mm Cannulated High Top Polyaxial Screw ASM, 50 mm Long |
| 00844856005624 | TI 6.5 mm Cannulated High Top Polyaxial Screw ASM, 45 mm Long |
| 00844856005617 | TI 6.5 mm Cannulated High Top Polyaxial Screw ASM, 40 mm Long |
| 00844856005600 | TI 6.5 mm Cannulated High Top Polyaxial Screw ASM, 35 mm Long |
| 00844856005594 | TI 6.5 mm Cannulated High Top Polyaxial Screw ASM, 30 mm Long |
| 00844856005587 | TI 5.5 mm Cannulated High Top Polyaxial Screw ASM, 50 mm Long |
| 00844856005570 | TI 5.5 mm Cannulated High Top Polyaxial Screw ASM, 45 mm Long |
| 00844856005563 | TI 5.5 mm Cannulated High Top Polyaxial Screw ASM, 40 mm Long |
| 00844856005556 | TI 5.5 mm Cannulated High Top Polyaxial Screw ASM, 35 mm Long |
| 00844856005549 | TI 5.5 mm Cannulated High Top Polyaxial Screw ASM, 30 mm Long |
| 00844856005532 | TI 4.5 mm Cannulated High Top Polyaxial Screw ASM, 45 mm Long |
| 00844856005525 | TI 4.5 mm Cannulated High Top Polyaxial Screw ASM, 40 mm Long |
| 00844856005518 | TI 4.5 mm Cannulated High Top Polyaxial Screw ASM, 35 mm Long |
| 00844856005501 | TI 4.5 mm Cannulated High Top Polyaxial Screw ASM, 30 mm Long |
| 00844856062429 | FIXED BRIDGE, 22mm |
| 00844856062412 | FIXED BRIDGE, 20mm |
| 00844856062405 | FIXED BRIDGE, 18mm |
| 00844856062399 | FIXED BRIDGE, 16mm |
| 00844856028845 | PRE CONTOURED CP ROD 5.5 x 3cm NON-BROACHED |
| 00844856002593 | PRE CONTOURED CP ROD 5.5 x 13cm NON-BROACHED |
| 00844856002579 | PRE CONTOURED CP ROD 5.5 x 11cm NON-BROACHED |
| 00844856002562 | PRE CONTOURED CP ROD 5.5 x 10cm NON-BROACHED |
| 00844856002555 | PRE CONTOURED CP ROD 5.5 x 9cm NON-BROACHED |
| 00844856002531 | PRE CONTOURED CP ROD 5.5 x 7cm NON-BROACHED |
| 00844856002517 | PRE CONTOURED CP ROD 5.5 x 5cm NON-BROACHED |
| 00844856002500 | PRE CONTOURED CP ROD 5.5 x 4cm NON-BROACHED |
| 00840967111544 | 30° Offset Connector, Right |
| 00840967111537 | 30° Offset Connector, Left |
| 00844856053441 | ZODIAC DEFORMITY UNIPLANAR IMPLANTS TI |
| 00844856053434 | ZODIAC DEFORMITY IMPLANTS 4.0 TI |
| 00844856053427 | ZODIAC TI DEFORMITY MONOAXIAL SCREW SET |
| 00844856053410 | ZODIAC DEFORMITY PELVIC IMPL/INSTR TI |
| 00844856053403 | ZODIAC DEFORMITY IMPLANTS TI SET 3 |
| 00844856053397 | ZODIAC DEFORMITY IMPLANTS TI SET 2 |
| 00844856053380 | ZODIAC DEFORMITY IMPLANTS TI SET 1 |
Trademark Results [Zodiac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZODIAC 98420362 not registered Live/Pending |
Albaugh, LLC 2024-02-26 |
 ZODIAC 98118473 not registered Live/Pending |
Connor Chiu 2023-08-04 |
 ZODIAC 97341502 not registered Live/Pending |
Haisha , Ronald 2022-03-31 |
 ZODIAC 97316034 not registered Live/Pending |
Pearlman, Stephen 2022-03-16 |
 ZODIAC 88213069 not registered Live/Pending |
PolyOne Corporation 2018-11-30 |
 ZODIAC 88169936 not registered Dead/Abandoned |
IND BEVERAGES LLC 2018-10-25 |
 ZODIAC 87960516 not registered Live/Pending |
DEFCON INDUSTRIES, LLC 2018-06-13 |
 ZODIAC 87655824 not registered Dead/Abandoned |
1.4G HOLDINGS, LLC 2017-10-23 |
 ZODIAC 87004641 5454118 Live/Registered |
Zodiac Inc. 2016-04-18 |
 ZODIAC 86929390 not registered Dead/Abandoned |
CVCStones, LLC 2016-03-04 |
 ZODIAC 86756562 4991754 Live/Registered |
Xuelian Lu 2015-09-15 |
 ZODIAC 86419381 not registered Dead/Abandoned |
Bentley Mills, Inc. 2014-10-09 |
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