Gibralt®
GUDID M711050040735550
Posterior Cervical, Rod to Rod Wedding Band Connector, Ø3.5-Ø5.5mm, Ti 6Al 4V (ELI)
Innovasis, Inc.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | M711050040735550 |
| NIH Device Record Key | b9bf7a66-98fb-4acf-8f12-af2e7ae27320 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gibralt® |
| Version Model Number | 05-004-07-3555 |
| Company DUNS | 156567492 |
| Company Name | Innovasis, Inc. |
| 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 | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711050040735550 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192354
FDA Product Code
| NKG | Posterior Cervical Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
[M711050040735550]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-08 |
| Device Publish Date | 2024-02-29 |
On-Brand Devices [Gibralt®]
| M711050002035100 | Posterior Cervical Screw Assembly, 3.5mm x 10mm, Ti 6Al 4V (ELI) |
| M711050002045450 | Posterior Cervical Screw Assembly, 4.5mm X 45mm, Ti 6Al 4V (ELI) |
| M711050002045400 | Posterior Cervical Screw Assembly, 4.5mm X 40mm, Ti 6Al 4V (ELI) |
| M711050002045350 | Posterior Cervical Screw Assembly, 4.5mm X 35mm, Ti 6Al 4V (ELI) |
| M711050002045300 | Posterior Cervical Screw Assembly, 4.5mm X 30mm, Ti 6Al 4V (ELI) |
| M711050002045250 | Posterior Cervical Screw Assembly, 4.5mm X 25mm Ti 6Al 4V (ELI) |
| M711050002045200 | Posterior Cervical Screw Assembly, 4.5mm X 20mm, Ti 6Al 4V (ELI) |
| M711050002040400 | Posterior Cervical Screw Assembly, 4.0mm X 40mm, Ti 6Al 4V (ELI) |
| M711050002040380 | Posterior Cervical Screw Assembly, 4.0mm X 38mm, Ti 6Al 4V (ELI) |
| M711050002040360 | Posterior Cervical Screw Assembly, 4.0mm X 36mm, Ti 6Al 4V (ELI) |
| M711050002040340 | Posterior Cervical Screw Assembly, 4.0mm X 34mm, Ti 6Al 4V (ELI) |
| M711050002040320 | Posterior Cervical Screw Assembly, 4.0mm X 32mm, Ti 6Al 4V (ELI) |
| M711050002040300 | Posterior Cervical Screw Assembly, 4.0mm X 30mm, Ti 6Al 4V (ELI) |
| M711050002040280 | Posterior Cervical Screw Assembly, 4.0mm X 28mm, Ti 6Al 4V (ELI) |
| M711050002040260 | Posterior Cervical Screw Assembly, 4.0mm X 26mm, Ti 6Al 4V (ELI) |
| M711050002040240 | Posterior Cervical Screw Assembly, 4.0mm X 24mm, Ti 6Al 4V (ELI) |
| M711050002040220 | Posterior Cervical Screw Assembly, 4.0mm X 22mm Ti 6Al 4V (ELI) |
| M711050002040200 | Posterior Cervical Screw Assembly, 4.0mm X 20mm Ti 6Al 4V (ELI) |
| M711050002040180 | Posterior Cervical Screw Assembly, 4.0mm X 18mm, Ti 6Al 4V (ELI) |
| M711050002040160 | Posterior Cervical Screw Assembly, 4.0mm X 16mm, Ti 6Al 4V (ELI) |
| M711050002040140 | Posterior Cervical Screw Assembly, 4.0mm X 14mm, Ti 6Al 4V (ELI) |
| M711050002040120 | Posterior Cervical Screw Assembly, 4.0mm X 12mm, Ti 6Al 4V (ELI) |
| M711050002040100 | Posterior Cervical Screw Assembly, 4.0mm X 10mm, Ti 6Al 4V (ELI) |
| M711050002035400 | Posterior Cervical Screw Assembly, 3.5mm X 40mm, Ti 6Al 4V (ELI) |
| M711050002035380 | Posterior Cervical Screw Assembly, 3.5mm X 38mm, Ti 6Al 4V (ELI) |
| M711050002035360 | Posterior Cervical Screw Assembly, 3.5mm X 36mm, Ti 6Al 4V (ELI) |
| M711050002035340 | Posterior Cervical Screw Assembly, 3.5mm X 34mm, Ti 6Al 4V (ELI) |
| M711050002035320 | Posterior Cervical Screw Assembly, 3.5mm X 32mm, Ti 6Al 4V (ELI) |
| M711050002035300 | Posterior Cervical Screw Assembly, 3.5mm X 30mm, Ti 6Al 4V (ELI) |
| M711050002035280 | Posterior Cervical Screw Assembly, 3.5mm X 28mm, Ti 6Al 4V (ELI) |
| M711050002035260 | Posterior Cervical Screw Assembly, 3.5mm X 26mm, Ti 6Al 4V (ELI) |
| M711050002035240 | Posterior Cervical Screw Assembly, 3.5mm X 24mm, Ti 6Al 4V (ELI) |
| M711050002035220 | Posterior Cervical Screw Assembly, 3.5mm X 22mm, Ti 6Al 4V (ELI) |
| M711050002035200 | Posterior Cervical Screw Assembly, 3.5mm X 20mm, Ti 6Al 4V (ELI) |
| M711050002035180 | Posterior Cervical Screw Assembly, 3.5mm X 18mm, Ti 6Al 4V (ELI) |
| M711050002035160 | Posterior Cervical Screw Assembly, 3.5mm X 16mm, Ti 6Al 4V (ELI) |
| M711050002640260 | Posterior Cervical Screw Assembly, Smooth, 4.0mm X 26mm, Ti 6Al 4V (ELI) |
| M711050002640200 | Posterior Cervical Screw Assembly, Smooth, 4.0mm X 20mm, Ti 6Al 4V (ELI) |
| M711050002635460 | Posterior Cervical Screw Assembly, Smooth, 3.5mm X 46mm, Ti 6Al 4V (ELI) |
| M711050060135050 | Posterior Cervical, Hook, Offset, Left, 3.5mm Rod, Ti 6Al 4V (ELI) |
| M711050060135040 | Posterior Cervical, Hook, Offset, Right, 3.5mm Rod , Ti 6Al 4V (ELI) |
| M711050060135030 | Posterior Cervical, Hook, 3.5mm Rod, Right Angle , Ti 6Al 4V (ELI) |
| M711050060135020 | Posterior Cervical, Hook, 3.5mm Rod, Left Angle , Ti 6Al 4V (ELI) |
| M711050060135010 | Posterior Cervical, Hook, 3.5mm Rod, Straight , Ti 6Al 4V (ELI) |
| M711050040735600 | Posterior Cervical, Rod to Rod Wedding Band Connector, Ø3.5-Ø6.0mm, Ti 6Al 4V (ELI) |
| M711050040735550 | Posterior Cervical, Rod to Rod Wedding Band Connector, Ø3.5-Ø5.5mm, Ti 6Al 4V (ELI) |
| M711050040535350 | Posterior Cervical, Rod to Rod Inline Connector Ø3.5mm, Ti 6Al 4V (ELI) |
| M711050040044520 | Posterior Cervical, Connector, Rod to Rod, 44-52mm, Ti 6Al 4V (ELI) |
| M711050040038480 | Posterior Cervical, Connector, Rod to Rod, 38-48mm, Ti 6Al 4V (ELI) |
| M711050040032420 | Posterior Cervical, Connector, Rod to Rod, 32-42mm, Ti 6Al 4V (ELI) |
Trademark Results [Gibralt]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GIBRALT 88578157 not registered Live/Pending |
Pfizer Inc. 2019-08-14 |
 GIBRALT 87125959 not registered Live/Pending |
Agouron Pharmaceuticals, LLC 2016-08-03 |
 GIBRALT 85831543 not registered Dead/Abandoned |
AGOURUN PHARMACEUTICALS, LLC 2013-01-24 |
 GIBRALT 78971429 not registered Dead/Abandoned |
Agouron Pharmaceuticals, Inc. 2006-09-11 |
 GIBRALT 78233093 not registered Dead/Abandoned |
Agouron Pharmaceuticals, Inc. 2003-04-02 |
 GIBRALT 77895757 4102820 Live/Registered |
Exactech, Inc. 2009-12-17 |
 GIBRALT 77766031 not registered Dead/Abandoned |
Agouron Pharmaceuticals, Inc. 2009-06-23 |
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