| Primary Device ID | 10888857289710 |
| NIH Device Record Key | 30a18f3a-349c-48b5-bec3-6a708796609b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PYRENEES Cervical Plate System |
| Version Model Number | SP-872 |
| Catalog Number | SP-872 |
| Company DUNS | 146060863 |
| Company Name | K2M, 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857289710 [Primary] |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
[10888857289710]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-08 |
| Device Publish Date | 2024-04-30 |
| 10888857171565 | Clip |
| 10888857113312 | Tap with Stop Size 10 mm |
| 10888857113268 | Anti-Torque Guide |
| 10888857113237 | Tap Size 10 mm |
| 10888857113220 | Awl Size 10 mm |
| 10888857113213 | Drill Size Ø3.0x16 mm |
| 10888857113206 | Drill Size Ø3.0x14 mm |
| 10888857113190 | Drill Size Ø3.0x12 mm |
| 10888857030558 | Clip Size 1 mm |
| 10888857247314 | Retaining Driver Size 13 |
| 10888857030480 | Fast Awl Size 10 mm |
| 10888857030350 | Capture Driver, Sleeve Size 10 |
| 10888857030299 | Torque Limiting Handle Size 20 in-lbs (2.3 N-m) |
| 10888857030275 | Drill, No Trocar Size Ø2.3x14 mm |
| 10888857030268 | Drill, No Trocar Size Ø2.3x12 mm |
| 10888857030251 | Drill, No Trocar Size Ø2.3x10 mm |
| 10888857030244 | Non-Tapered Torque Driver Size 10 |
| 10888857030220 | Non-Tapered Torque Driver |
| 10888857030213 | Spring Loaded Awl Size 10 mm |
| 10888857030190 | Screw Extractor |
| 10888857030183 | Tapered Driver Size 10 |
| 10888857030176 | Freehand Tap Size Ø2.3x10 mm |
| 10888857030169 | Tap Size Ø2.3x10 mm |
| 10888857030152 | Awl Size 10 mm |
| 10888857030145 | Temporary Pin Inserter |
| 10888857030138 | Drill Size Ø2.3x16 mm |
| 10888857030121 | Drill Size Ø2.3x14 mm |
| 10888857030114 | Drill Size Ø2.3x12 mm |
| 10888857030107 | Drill Size Ø2.3x10 mm |
| 10888857030091 | Thread Former |
| 10888857030039 | Drill Size Ø2.3x16 mm |
| 10888857030022 | Drill Size Ø2.3x14 mm |
| 10888857030015 | Drill Size Ø2.3x12 mm |
| 10888857030008 | Drill Size Ø2.3x10 mm |
| 10888857029989 | Torque Limiting Handle (1/4" Square Quick Connect) |
| 10888857029972 | Plate Bender, Cervical Universal |
| 10888857029941 | Reduction Screw Size 14 mm |
| 10888857029934 | Reduction Screw Size 12 mm |
| 10888857029910 | Caliper |
| 10888857029859 | Freehand Tap Size Ø4.0x10 mm |
| 10888857029842 | Temporary Fixation Pin |
| 10888857029835 | Spring Loaded Awl Size 10 mm |
| 10888857029828 | Tap Size Ø4.0x10 mm |
| 10888857029781 | 2.3mm Stop Drill Size 10mm |
| 10888857029682 | Awl Size 10 mm |
| 10888857029675 | 2.3mm Stop Drill Size 16mm |
| 10888857029668 | 2.3mm Stop Drill Size 14mm |
| 10888857029651 | 2.3mm Stop Drill Size 12mm |
| 10888857029637 | Screw Extractor |
| 10888857260498 | Tap Size ø2.3mm x 16mm |