INFINITY™ Occipitocervical Upper Thoracic System
GUDID 00643169527096
XS CERVICAL MAS G3603010 3.0 X 10MM
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00643169527096 |
| NIH Device Record Key | bedcd03c-00c2-459c-919e-fccd9c76da7c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INFINITY™ Occipitocervical Upper Thoracic System |
| Version Model Number | G3603010 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169527096 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163375
FDA Product Code
| NKG | Orthosis, cervical pedicle screw spinal fixation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-01 |
| Device Publish Date | 2018-07-01 |
On-Brand Devices [INFINITY™ Occipitocervical Upper Thoracic System]
| 00643169839656 | CADDY LID 3607035 CT MODULE DOMINO |
| 00643169839649 | CADDY 3607034 CT MODULE DOMINO |
| 00643169839632 | CADDY LID 3607033 CT MODULE 4.0MM MAS |
| 00643169839625 | CADDY 3607032 CT MODULE 4.0MM MAS |
| 00643169839618 | CADDY LID 3607031 CT MODULE 3.5MM MAS |
| 00643169839601 | CADDY 3607030 CT MODULE 3.5MM MAS |
| 00643169839595 | TRAY 3607029 CT MODULE IMPLANT 2 OF 2 |
| 00643169839588 | TRAY 3607028 CT MODULE IMPLANT 1 OF 2 |
| 00643169839571 | TRAY 3607026 COMPLEX INSTRUMENT |
| 00643169839564 | CADDY LID 3607024 C3-C7 MODULE PRCT ROD |
| 00643169839557 | CADDY 3607023 C3-C7 MODULE PRECUT ROD |
| 00643169839540 | CADDY LID 3607022 C3-C7 MODULE SET SCRW |
| 00643169839533 | CADDY 3607021 C3-C7 MODULE SET SCREW |
| 00643169839526 | CADDY LID 3607020 C3-C7 MODULE CONNECTR |
| 00643169839519 | CADDY 3607019 C3-C7 MODULE CONNECTOR |
| 00643169839502 | CADDY LID 3607018 C3-C7 MODULE 4.0M MAS |
| 00643169839496 | CADDY 3607017 C3-C7 MODULE 4.0MM MAS |
| 00643169839489 | CADDY LID 3607016 C3-C7 MODULE 3.5M MAS |
| 00643169839472 | CADDY 3607015 C3-C7 MODULE 3.5MM MAS |
| 00643169839465 | TRAY 3607014 C3-C7 IMPLANT 2 OF 2 |
| 00643169839458 | TRAY 3607013 C3-C7 IMPLANT 1 OF 2 |
| 00643169839441 | TRAY 3607011 C3-C7 INSTRUMENT 2 OF 2 |
| 00643169839434 | TRAY 3607010 C3-C7 INSTRUMENT 1 OF 2 |
| 00643169839427 | CADDY LID 3607008 OC PLATE AND SCRW CONN |
| 00643169839410 | CADDY 3607007 OC PLATE AND SCREW CONN |
| 00643169839403 | CADDY LID 3607006 OC SCREW |
| 00643169839397 | CADDY 3607005 OC SCREW |
| 00643169839380 | CADDY LID 3607004 OC-C2 MODULE MAS |
| 00643169839373 | CADDY 3607003 OC-C2 MODULE MAS |
| 00643169839366 | TRAY 3607002 OC-C2 IMPLANT |
| 00643169839359 | TRAY 3607001 OC-C2 INSTRUMENT |
| 00643169624160 | OCCIPITAL 3600211 PRE CURVED CCM 3.5X200 |
| 00643169624153 | OCCIPITAL 3600201 PRE CURVED TI 3.5X200 |
| 00643169624146 | ROD 3605240 STANDARD 3.5MM X 240MM |
| 00643169624139 | ROD 3605120 STANDARD 3.5MM X 120MM |
| 00643169624122 | ROD 3602240 STANDARD 3.2MM X 240MM |
| 00643169624115 | ROD 3602120 STANDARD 3.2MM X 120MM |
| 00643169624108 | ROD 3603780 PRE-CUT 3.5MM X 80MM |
| 00643169624092 | ROD 3603770 PRE-CUT 3.5MM X 70MM |
| 00643169624085 | ROD 3603760 PRE-CUT 3.5MM X 60MM |
| 00643169624078 | ROD 3603750 PRE-CUT 3.5MM X 50MM |
| 00643169624061 | ROD 3603740 PRE-CUT 3.5MM X 40MM |
| 00643169624054 | ROD 3603730 PRE-CUT 3.5MM X 30MM |
| 00643169624047 | ROD 3603725 PRE-CUT 3.5MM X 25MM |
| 00643169624030 | ROD 3603807 TAPERED 3.5/5.5 X 420MM CCM |
| 00643169624023 | ROD 3603806 TAPERED 3.5/4.75 X 420MM CCM |
| 00643169624016 | ROD 3603707 TAPERED 3.5/5.5MM X 420MM |
| 00643169624009 | ROD 3603706 TAPERED 3.5/4.75MM X 420MM |
| 00643169556614 | SCREW G360T0514 OC TAPERED 5.0 X 14MM |
| 00643169556607 | SCREW G360T0512 OC TAPERED 5.0 X 12MM |
Trademark Results [INFINITY]
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