Implate IMP-WC-0705
GUDID 00841506104614
SKELETAL DYNAMICS L.L.C.
Arthrodesis nail, non-sterile| Primary Device ID | 00841506104614 |
| NIH Device Record Key | ad7e5733-e09d-4639-b571-c6e43b466ae9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Implate |
| Version Model Number | IMPLATE Connector, 7mm x 5° |
| Catalog Number | IMP-WC-0705 |
| Company DUNS | 869056148 |
| Company Name | SKELETAL DYNAMICS L.L.C. |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841506104614 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092720
FDA Product Code
| HSP | SPLINT, TRACTION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-13 |
On-Brand Devices [Implate]
| 00841506104645 | IMPLATE Connector, 12mm x 10° |
| 00841506104638 | IMPLATE Connector, 12mm x 5° |
| 00841506104621 | IMPLATE Connector, 7mm x 10° |
| 00841506104614 | IMPLATE Connector, 7mm x 5° |
| 00841506104607 | IMPLATE Connector, 2mm x 10° |
| 00841506104591 | IMPLATE Connector, 2mm x 5° |
| 00841506103709 | Unicortical Screw, 2.8mm x 14.0mm, Ti |
| 00841506103693 | Unicortical Screw, 2.8mm x 12.0mm, Ti |
| 00841506103686 | Unicortical Screw, 2.8mm x 10.0mm, Ti |
| 00841506103679 | Unicortical Screw, 2.8mm x 8.0mm, Ti |
| 00841506103662 | Unicortical Screw, 2.8mm x 7.0mm, Ti |
| 00841506103655 | Unicortical Screw, 2.8mm x 6.0mm, Ti |
| 00841506103648 | Unicortical Screw, 2.8mm x 5.0mm, Ti |
| 00841506103631 | Unicortical Screw, 2.8mm x 4.0mm, Ti |
| 00841506103105 | Set Screw, 3.0mm x 2.0mm, CoCr |
| 00841506102443 | IMPLATE Connector, 12mm x 22.5° |
| 00841506102436 | IMPLATE Connector, 12mm x 15° |
| 00841506102429 | IMPLATE Connector, 12mm x 7.5° |
| 00841506102412 | IMPLATE Connector, 12mm x 0° |
| 00841506102405 | IMPLATE Connector, 7mm x 22.5° |
| 00841506102399 | IMPLATE Connector, 7mm x 15° |
| 00841506102382 | IMPLATE Connector, 7mm x 7.5° |
| 00841506102375 | IMPLATE Connector, 7mm x 0° |
| 00841506102368 | IMPLATE Connector, 2mm x 22.5° |
| 00841506102351 | IMPLATE Connector, 2mm x 15° |
| 00841506102344 | IMPLATE Connector, 2mm x 7.5° |
| 00841506102337 | IMPLATE Connector, 2mm x 0° |
| 00841506102320 | IMPLATE Wrist Arthrodesis Nail System |
| 00841506102313 | IMPLATE Spreader, Wrist Arthrodesis Nails |
| 00841506102306 | IMPLATE Rasp 2, Distal Radius, 7.0mm x 70mm |
| 00841506102290 | IMPLATE Rasp 1, Distal Radius, 5.5mm x 70mm |
| 00841506102283 | IMPLATE Reamer 5, Metacarpal, 5.0mm x 87mm |
| 00841506102276 | IMPLATE Reamer 4, Metacarpal, 4.5mm x 87mm |
| 00841506102269 | IMPLATE Reamer 3, Metacarpal, 4.0mm x 87mm |
| 00841506102252 | IMPLATE Reamer 2, Metacarpal, 3.4mm x 87mm |
| 00841506102245 | IMPLATE Reamer 1, Metacarpal, 2.7mm x 87mm |
| 00841506102238 | IMPLATE, Minimum Gap Gauge |
| 00841506102221 | IMPLATE Awl, Wrist Arthrodesis Nails |
| 00841506102214 | IMPLATE Lock Screw, Unicort. Drill Guide |
| 00841506102207 | IMPLATE Uni Drill Guide, Drill Sleeve |
| 00841506102191 | IMPLATE Uni Drill Guide, DRMC Nails |
| 00841506102184 | IMPLATE Uni Drill Guide, Depth Gauge |
| 00841506102177 | IMPLATE Nail, Metacarpal, Standard, 4.6mm |
| 00841506102160 | IMPLATE Nail, Metacarpal, Standard, 4.0mm |
| 00841506102153 | IMPLATE Nail, Metacarpal, Mini |
| 00841506102146 | IMPLATE Rasp, Flaring and Troughing |
| 00841506102139 | IMPLATE Drill, Unicortical 3mm x 41mm |
| 00841506102122 | IMPLATE Nail, Distal Radius, Short, Ti |
| 00841506102115 | IMPLATE Nail, Distal Radius, Long, Ti |
| 00841506102061 | Handle, Mini Quick Connect, Fixed |
Trademark Results [Implate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMPLATE 85031895 3967758 Live/Registered |
SKELETAL DYNAMICS, INC. 2010-05-06 |
 IMPLATE 78732014 not registered Dead/Abandoned |
Amgen Inc. 2005-10-12 |
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