ACIS 08843608S
GUDID H98108843608S0
ACIS IMPLANT-STERILE LORDOTIC/SMALL-8MM HEIGHT
SYNTHES (U.S.A.) LP
Polymeric spinal interbody fusion cage| Primary Device ID | H98108843608S0 |
| NIH Device Record Key | 1c0740e2-df81-4a5c-b873-297458adb4e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACIS |
| Version Model Number | 08.843.608S |
| Catalog Number | 08843608S |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | true |
| 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
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034762609 [Primary] |
| HIBCC | H98108843608S0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120275
FDA Product Code
| ODP | Intervertebral fusion device with bone graft, cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
[H98108843608S0]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-09-02 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [ACIS]
| H981088438120 | ACIS IMPLANT CONVEX/SMALL 12MM HEIGHT |
| H981088438110 | ACIS IMPLANT CONVEX/SMALL 11MM HEIGHT |
| H981088438100 | ACIS IMPLANT CONVEX/SMALL 10MM HEIGHT |
| H981088438090 | ACIS IMPLANT CONVEX/SMALL 9MM HEIGHT |
| H981088438080 | ACIS IMPLANT CONVEX/SMALL 8MM HEIGHT |
| H981088438070 | ACIS IMPLANT CONVEX/SMALL 7MM HEIGHT |
| H981088438060 | ACIS IMPLANT CONVEX/SMALL 6MM HEIGHT |
| H981088438050 | ACIS IMPLANT CONVEX/SMALL 5MM HEIGHT |
| H981088437120 | ACIS IMPLANT PARALLEL/SMALL 12MM HEIGHT |
| H981088437110 | ACIS IMPLANT PARALLEL/SMALL 11MM HEIGHT |
| H981088437100 | ACIS IMPLANT PARALLEL/SMALL 10MM HEIGHT |
| H981088437090 | ACIS IMPLANT PARALLEL/SMALL 9MM HEIGHT |
| H981088437080 | ACIS IMPLANT PARALLEL/SMALL 8MM HEIGHT |
| H981088437070 | ACIS IMPLANT PARALLEL/SMALL 7MM HEIGHT |
| H981088437060 | ACIS IMPLANT PARALLEL/SMALL 6MM HEIGHT |
| H981088437050 | ACIS IMPLANT PARALLEL/SMALL 5MM HEIGHT |
| H981088436120 | ACIS IMPLANT LORDOTIC/SMALL 12MM HEIGHT |
| H981088436110 | ACIS IMPLANT LORDOTIC/SMALL 11MM HEIGHT |
| H981088436100 | ACIS IMPLANT LORDOTIC/SMALL 10MM HEIGHT |
| H981088436090 | ACIS IMPLANT LORDOTIC/SMALL 9MM HEIGHT |
| H981088436080 | ACIS IMPLANT LORDOTIC/SMALL 8MM HEIGHT |
| H981088436070 | ACIS IMPLANT LORDOTIC/SMALL 7MM HEIGHT |
| H981088436060 | ACIS IMPLANT LORDOTIC/SMALL 6MM HEIGHT |
| H981088436050 | ACIS IMPLANT LORDOTIC/SMALL 5MM HEIGHT |
| H981088434120 | ACIS IMPLANT PARALLEL/LARGE 12MM HEIGHT |
| H981088434110 | ACIS IMPLANT PARALLEL/LARGE 11MM HEIGHT |
| H981088434100 | ACIS IMPLANT PARALLEL/LARGE 10MM HEIGHT |
| H981088434090 | ACIS IMPLANT PARALLEL/LARGE 9MM HEIGHT |
| H981088434080 | ACIS IMPLANT PARALLEL/LARGE 8MM HEIGHT |
| H981088434070 | ACIS IMPLANT PARALLEL/LARGE 7MM HEIGHT |
| H981088434060 | ACIS IMPLANT PARALLEL/LARGE 6MM HEIGHT |
| H981088434050 | ACIS IMPLANT PARALLEL/LARGE 5MM HEIGHT |
| H981088433120 | ACIS IMPLANT LORDOTIC/LARGE 12MM HEIGHT |
| H981088433110 | ACIS IMPLANT LORDOTIC/LARGE 11MM HEIGHT |
| H981088433100 | ACIS IMPLANT LORDOTIC/LARGE 10MM HEIGHT |
| H981088433090 | ACIS IMPLANT LORDOTIC/LARGE 9MM HEIGHT |
| H981088433080 | ACIS IMPLANT LORDOTIC/LARGE 8MM HEIGHT |
| H981088433070 | ACIS IMPLANT LORDOTIC/LARGE 7MM HEIGHT |
| H981088433060 | ACIS IMPLANT LORDOTIC/LARGE 6MM HEIGHT |
| H981088433050 | ACIS IMPLANT LORDOTIC/LARGE 5MM HEIGHT |
| H981088432120 | ACIS IMPLANT CONVEX/STANDARD 12MM HEIGHT |
| H981088432110 | ACIS IMPLANT CONVEX/STANDARD 11MM HEIGHT |
| H981088432100 | ACIS IMPLANT CONVEX/STANDARD 10MM HEIGHT |
| H981088432090 | ACIS IMPLANT CONVEX/STANDARD 9MM HEIGHT |
| H981088432080 | ACIS IMPLANT CONVEX/STANDARD 8MM HEIGHT |
| H981088432070 | ACIS IMPLANT CONVEX/STANDARD 7MM HEIGHT |
| H981088432060 | ACIS IMPLANT CONVEX/STANDARD 6MM HEIGHT |
| H981088432050 | ACIS IMPLANT CONVEX/STANDARD 5MM HEIGHT |
| H981088431120 | ACIS IMPLANT PARALLEL/STANDARD 12MM HEIGHT |
| H981088431110 | ACIS IMPLANT PARALLEL/STANDARD 11MM HEIGHT |
Trademark Results [ACIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACIS 98018300 not registered Live/Pending |
ChemValve-Schmid Americas, LLC 2023-05-30 |
 ACIS 88379244 not registered Live/Pending |
Sivarts, Inc. 2019-04-10 |
 ACIS 86296121 4691329 Live/Registered |
Federal Home Loan Mortgage Corporation 2014-05-30 |
 ACIS 85248128 4242661 Live/Registered |
DEPUY SYNTHES, INC. 2011-02-22 |
 ACIS 85040095 not registered Dead/Abandoned |
World Energy Systems Incorporated 2010-05-17 |
 ACIS 78061056 2633372 Dead/Cancelled |
Coemergence, Inc. 2001-04-30 |
 ACIS 76392450 2677746 Live/Registered |
American Council for International Studies, Inc. 2002-04-04 |
 ACIS 76175358 2716264 Dead/Cancelled |
CARL ZEISS MICROIMAGING AIS, INC. 2000-11-30 |
 ACIS 75876549 2412450 Live/Registered |
American Council for International Studies 1999-12-21 |
 ACIS 75863023 2587168 Dead/Cancelled |
GAB Robins North America, Inc. 1999-12-02 |
 ACIS 75532219 not registered Dead/Abandoned |
American Council for International Studies 1998-08-06 |
 ACIS 75532119 not registered Dead/Abandoned |
American Council for International Studies 1998-08-06 |
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