InSpan
GUDID 00190361028284
SLIM, INSPAN, ISP PLATE ASSEMBLY
SPINEFRONTIER, INC.
Interspinous spinal fixation implant| Primary Device ID | 00190361028284 |
| NIH Device Record Key | 2efa4ff3-4682-4771-8863-a27e49ba7a10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InSpan |
| Version Model Number | 01-61100-1845 |
| Company DUNS | 002003243 |
| Company Name | SPINEFRONTIER, 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
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com | |
| Phone | +1(866)914-7717 |
| customerservice@kicventures.com |
Device Dimensions
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
| Length | 45 Millimeter |
| Width | 18 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190361028284 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102020
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
[00190361028284]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-02 |
| Device Publish Date | 2021-01-25 |
On-Brand Devices [InSpan]
| 00190361024644 | SLIM, INSPAN, ISP PLATE ASSEMBLY |
| 00190361024637 | SLIM, INSPAN, ISP PLATE ASSEMBLY |
| 00190361024620 | SLIM, INSPAN, ISP PLATE ASSEMBLY |
| 00190361024613 | SLIM, INSPAN, ISP PLATE ASSEMBLY |
| 00190361024606 | SLIM, INSPAN, ISP PLATE ASSEMBLY |
| 00190361024590 | SLIM, INSPAN, ISP PLATE ASSEMBLY |
| 00190361028291 | SLIM, INSPAN, ISP PLATE ASSEMBLY |
| 00190361028284 | SLIM, INSPAN, ISP PLATE ASSEMBLY |
Trademark Results [InSpan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSPAN 85168993 4046830 Live/Registered |
SpineFrontier, Inc. 2010-11-04 |
 INSPAN 75565332 not registered Dead/Abandoned |
ANDREW CORPORATION 1998-10-05 |
 INSPAN 74194281 1799989 Dead/Cancelled |
Intergraph Corporation 1991-08-13 |
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