STABOLT
GUDID 03613720193142
STABOLT SCREW SH8 Ø 6.5mm/35mm
MEDICREA INTERNATIONAL
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 03613720193142 |
| NIH Device Record Key | d69f5528-4ff2-4803-ac8e-66de747aa95a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STABOLT |
| Version Model Number | B14046535 |
| Company DUNS | 383228632 |
| Company Name | MEDICREA INTERNATIONAL |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03613720193142 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121323
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
[03613720193142]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-05-23 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [STABOLT]
| 03613720215547 | SCREW REMOVER |
| 03613720215530 | U-JOINT SELF RETAINING SCREWDRIVER |
| 03613720215509 | SCREW HOLDER |
| 03613720215493 | U-JOINT SCREWDRIVER |
| 03613720215486 | SPHERICAL SCREWDRIVER |
| 03613720215479 | STRAIGHT SCREWDRIVER |
| 03613720215462 | SHAFT HOLDER |
| 03613720215455 | IMPLANT HOLDER |
| 03613720215448 | SCREW HOLDER |
| 03613720210269 | DETACHABLE HOLDER |
| 03613720227410 | STABOLT SCREW SH8 Ø 5.5mm/25mm |
| 03613720215639 | SHARED INSTRUMENTS STABOLT / ALIF S/A TRAY |
| 03613720215622 | STABOLT ALIF S/A O-BATCH CASE |
| 03613720215608 | TRIAL FOR 130° LUMBOSACRAL PLATE |
| 03613720215592 | TRIAL FOR 115° LUMBOSACRAL PLATE |
| 03613720215585 | TRIAL FOR 130° LUMBOSACRAL PLATE |
| 03613720215578 | TRIAL FOR 115° LUMBOSACRAL PLATE |
| 03613720215561 | TRIAL ATTACHMENT FOR 4-HOLE PLATE |
| 03613720215554 | PLATE ANGLE GAUGE |
| 03613720215431 | VASCULAR RETRACTOR |
| 03613720215424 | AWL |
| 03613720215417 | TEMPORY HOLDING PIN |
| 03613720215400 | SLEEVE FOR DRILL |
| 03613720215394 | DRILL GUIDE |
| 03613720215387 | U-JOINT DRILL |
| 03613720215370 | STRAIGHT DRILL |
| 03613720193173 | STABOLT SCREW SH8 Ø 6.5mm/40mm |
| 03613720193166 | STABOLT SCREW SH8 Ø 6.5mm/40mm |
| 03613720193159 | STABOLT SCREW SH8 Ø 6.5mm/35mm |
| 03613720193142 | STABOLT SCREW SH8 Ø 6.5mm/35mm |
| 03613720193135 | STABOLT SCREW SH8 Ø 6.5mm/30mm |
| 03613720193128 | STABOLT SCREW SH8 Ø 6.5mm/30mm |
| 03613720193111 | STABOLT SCREW SH8 Ø 6.5mm/25mm |
| 03613720193104 | STABOLT SCREW SH8 Ø 6.5mm/25mm |
| 03613720193098 | STABOLT SCREW SH8 Ø 6.5mm/20mm |
| 03613720193081 | STABOLT SCREW SH8 Ø 6.5mm/20mm |
| 03613720193074 | STABOLT SCREW SH8 Ø 5.5mm/40mm |
| 03613720193067 | STABOLT SCREW SH8 Ø 5.5mm/40mm |
| 03613720193050 | STABOLT SCREW SH8 Ø 5.5mm/35mm |
| 03613720193043 | STABOLT SCREW SH8 Ø 5.5mm/35mm |
| 03613720193036 | STABOLT SCREW SH8 Ø 5.5mm/30mm |
| 03613720193029 | STABOLT SCREW SH8 Ø 5.5mm/30mm |
| 03613720193005 | STABOLT SCREW SH8 Ø 5.5mm/25mm |
| 03613720192992 | STABOLT SCREW SH8 Ø 5.5mm/20mm |
| 03613720192985 | STABOLT SCREW SH8 Ø 5.5mm/20mm |
| 03613720192978 | 3 HOLES LUMBOSACRAL PLATE Size 6 at 130° |
| 03613720192961 | 3 HOLES LUMBOSACRAL PLATE Size 6 at 115° |
| 03613720192954 | 3 HOLES LUMBOSACRAL PLATE Size 5 at 130° |
| 03613720192947 | 3 HOLES LUMBOSACRAL PLATE Size 5 at 115° |
| 03613720192930 | 3 HOLES LUMBOSACRAL PLATE Size 4 at 130° |
Trademark Results [STABOLT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STABOLT 79114420 4284492 Live/Registered |
MEDICREA INTERNATIONAL 2012-05-16 |
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