SureMAX
GUDID 00817662024646
Cervical Inserter with Guard Assembly
ADDITIVE IMPLANTS, LLC
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 00817662024646 |
| NIH Device Record Key | 28d93449-88e4-4873-be59-b5873fca4ebe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SureMAX |
| Version Model Number | 1 |
| Company DUNS | 057002266 |
| Company Name | ADDITIVE IMPLANTS, LLC |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com | |
| Phone | 6027958850 |
| quality@additiveimplant.com |
Device Dimensions
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
| Length | 203.3 Millimeter |
| Outer Diameter | 10 Millimeter |
| Lumen/Inner Diameter | 3.4 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817662024646 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182477
FDA Product Code
| LYQ | Accessories, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
[00817662024646]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2019-02-21 |
On-Brand Devices [SureMAX]
| 00817662024738 | Cervical Slap Hammer Handle - Egg |
| 00817662024721 | Cervical Slap Hammer Handle - Ergonomic |
| 00817662024707 | Top Barrier, Slap Hammer |
| 00817662024691 | Central Rod Nut, Slap Hammer |
| 00817662024684 | Central Rod, Slap Hammer |
| 00817662024677 | Cervical Slap Hammer Shaft |
| 00817662024660 | Cervical Slap Hammer |
| 00817662024653 | Cervical Inserter Rod |
| 00817662024646 | Cervical Inserter with Guard Assembly |
| 00817662024639 | Cervical Inserter Shaft with Guard |
| 00817662024622 | Cervical Inserter without Guard Assembly |
| 00817662024615 | Proximal Bushing |
| 00817662024608 | Cervical Inserter Shaft without Guard |
| 00817662024592 | Cervical Inserter with Guard |
| 00817662024585 | Cervical Inserter without Guard |
| 00817662020716 | SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 12mm |
| 00817662020709 | SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 11mm |
| 00817662020693 | SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 10mm |
| 00817662020686 | SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 9mm |
| 00817662020679 | SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 8mm |
| 00817662020662 | SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 7mm |
| 00817662020655 | SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 6mm |
| 00817662020648 | SureMAX Cervical Spacer, 0° Parallel Large (15mm x 18mm) x 5mm |
| 00817662020631 | SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 12mm |
| 00817662020624 | SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 11mm |
| 00817662020617 | SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 10mm |
| 00817662020600 | SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 9mm |
| 00817662020594 | SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 8mm |
| 00817662020587 | SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 7mm |
| 00817662020570 | SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 6mm |
| 00817662020563 | SureMAX Cervical Spacer, 0° Parallel Medium (14mm x 16mm) x 5mm |
| 00817662020556 | SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 12mm |
| 00817662020549 | SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 11mm |
| 00817662020532 | SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 10mm |
| 00817662020525 | SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 9mm |
| 00817662020518 | SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 8mm |
| 00817662020501 | SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 7mm |
| 00817662020495 | SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 6mm |
| 00817662020488 | SureMAX Cervical Spacer, 0° Parallel Small (12mm x 14mm) x 5mm |
| 00817662020471 | SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 12mm |
| 00817662020464 | SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 11mm |
| 00817662020457 | SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 10mm |
| 00817662020440 | SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 9mm |
| 00817662020433 | SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 8mm |
| 00817662020426 | SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 7mm |
| 00817662020419 | SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 6mm |
| 00817662020402 | SureMAX Cervical Spacer, 14° Hyperlordotic Large (15mm x 18mm) x 5mm |
| 00817662020396 | SureMAX Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 12mm |
| 00817662020389 | SureMAX Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 11mm |
| 00817662020372 | SureMAX Cervical Spacer, 14° Hyperlordotic Medium (14mm x 16mm) x 10mm |
Trademark Results [SureMAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUREMAX 88115736 5802312 Live/Registered |
Additive Implant LLC 2018-09-13 |
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