UNIPLATE 189721013
GUDID 10705034181127
UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 13mm
DEPUY SPINE, LLC
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 10705034181127 |
| NIH Device Record Key | df0a3ebb-84c7-44c8-b6bb-acc911fef541 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIPLATE |
| Version Model Number | 189721013 |
| Catalog Number | 189721013 |
| Company DUNS | 107105876 |
| Company Name | DEPUY 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 | 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
| 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 | 10705034181127 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082273
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
[10705034181127]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [UNIPLATE]
| 10705034224770 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT |
| 10705034224961 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM MARKING PIN |
| 10705034224886 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DRILL GUIDE - LATERAL ARM |
| 10705034224862 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM PLATE HOLDER |
| 10705034344416 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM PLATE CADDY (THREE LEVEL) |
| 10705034225104 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM CASE PLATE TAG |
| 10705034225074 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM PLATE CADDY LID (TWO-LEVEL) |
| 10705034225067 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM PLATE CADDY LID (ONE-LEVEL) |
| 10705034225050 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM PLATE CADDY (TWO-LEVEL) |
| 10705034225043 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM PLATE CADDY (ONE-LEVEL) |
| 10705034225005 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM PLATE CADDY (TWO-LEVEL) |
| 10705034224992 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM PLATE CADDY (ONE-LEVEL) |
| 10705034224985 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM SCREW CADDY |
| 10705034224978 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CASE AND TRAY |
| 10705034224688 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM AWL 7mm |
| 10705034224732 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM TAP SHAFT 12mm |
| 10705034180762 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-DRILLING 4.6 x 10mm |
| 10705034295213 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 66mm |
| 10705034295190 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 60mm |
| 10705034295145 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 45mm |
| 10705034181189 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 24mm |
| 10705034295206 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 63mm |
| 10705034295183 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 57mm |
| 10705034295176 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 54mm |
| 10705034295169 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 51mm |
| 10705034295152 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 48mm |
| 10705034181288 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 40mm |
| 10705034181271 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 38mm |
| 10705034181264 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 36mm |
| 10705034181257 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 34mm |
| 10705034181240 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 32mm |
| 10705034181233 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 30mm |
| 10705034181226 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 28mm |
| 10705034181219 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM TWO LEVEL PLATE 26mm |
| 10705034181202 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 28mm |
| 10705034181196 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 26mm |
| 10705034181172 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 22mm |
| 10705034181165 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 20mm |
| 10705034181158 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 18mm |
| 10705034181141 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 16mm |
| 10705034181134 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 14mm |
| 10705034181127 | UNIPLATE 2 ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 13mm |
| 10705034180816 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-DRILLING 4.6 x 16mm |
| 10705034180809 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-DRILLING 4.6 x 15mm |
| 10705034180793 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-DRILLING 4.6 x 14mm |
| 10705034180786 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-DRILLING 4.6 x 13mm |
| 10705034180779 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM SCREW, SELF-DRILLING 4.6 x 12mm |
| 10705034180755 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM LARGE DIAMETER SCREW 5.2 x 26mm |
| 10705034180717 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM LARGE DIAMETER SCREW 5.2 x 18mm |
| 10705034180700 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM LARGE DIAMETER SCREW 5.2 x 16mm |
Trademark Results [UNIPLATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNIPLATE 78485724 3160182 Live/Registered |
DePuy Synthes, Inc. 2004-09-17 |
 UNIPLATE 78175036 not registered Dead/Abandoned |
Jet Pur 2002-10-16 |
 UNIPLATE 77327808 not registered Dead/Abandoned |
Tac-Fast Systems Canada Limited 2007-11-13 |
 UNIPLATE 75588967 2334982 Live/Registered |
ATOTECH DEUTSCHLAND GMBH 1998-11-16 |
 UNIPLATE 73654643 1468891 Live/Registered |
AUDIO TECHNICA U.S., INC. 1987-04-13 |
 UNIPLATE 72343046 0892856 Dead/Expired |
F. D. FARNAM CO. 1969-11-10 |
 UNIPLATE 72307449 0883162 Live/Registered |
F. D. FARNAM CO. 1968-09-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.