| Primary Device ID | 10888857082557 |
| NIH Device Record Key | 581f64cc-5899-41d2-bc14-069ea94d30e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CHESAPEAKE Stabilization System |
| Version Model Number | 3608-90031 |
| Catalog Number | 3608-90031 |
| Company DUNS | 146060863 |
| Company Name | K2M, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | |
| 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 | 10888857082557 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
[10888857082557]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-09 |
| Device Publish Date | 2022-06-01 |
| 10888857404472 | Anti Torque Handle |
| 10888857083264 | Implant Inserter, Adjustable Stops |
| 10888857083011 | Ø3.5 mm Universal Drill, Screw Ø3.5x14 mm Screw |
| 10888857083004 | Universal Awl |
| 10888857082977 | Non-Tapered Universal Driver Size 10 |
| 10888857082960 | Universal Tapered Driver Size 10 |
| 10888857082953 | Universal Tap/Screw Ø3.5x14 mm Screw |
| 10888857082823 | Inner Shaft, Threaded |
| 10888857082793 | Single Barrel Drill/Screw Ø3.5x12 mm Screw |
| 10888857082779 | Ø3.5 mm Drill, Screw Ø3.5x14 mm Screw |
| 10888857082762 | Tap/Screw Ø3.5x14 mm Screw |
| 10888857082625 | Non-Tapered Driver Size 10 |
| 10888857082618 | Tapered Driver Size 10 |
| 10888857082601 | Implant Pusher |
| 10888857082595 | Awl |
| 10888857082588 | Ø3.5 mm Drill, Screw |
| 10888857082571 | 3-Screw Drill Guide Inserter Size 10 mm |
| 10888857082564 | 3-Screw Drill Guide Inserter Size 9 mm |
| 10888857082557 | 3-Screw Drill Guide Inserter Size 8 mm |
| 10888857082540 | 3-Screw Drill Guide Inserter Size 7 mm |
| 10888857082533 | 3-Screw Drill Guide Inserter Size 6 mm |
| 10888857082526 | 3-Screw Drill Guide Inserter Size 5 mm |
| 10888857082397 | Torque Limiting Handle Size 12 in-lbs (1.4 N-m) |
| 10888857182752 | Universal Tapered Driver Size 20 |
| 10888857157712 | Drill Guide, Inserter Clip |
| 10888857026582 | Expandable Drill Guide Size 17 mm |
| 10888857026551 | Expandable Drill Guide Size 11 mm |
| 10888857025745 | Zero Countersink Modular Tip Allograft |
| 10888857025721 | Zero Countersink Modular Tip Chesapeake |
| 10888857025714 | Universal Tap Size Ø5.25x20 mm |
| 10888857025684 | Universal Drill Size Ø5.5x20 mm |
| 10888857025646 | Awl Size 25 mm |
| 10888857025639 | Spring Loaded Awl Size 20 mm |
| 10888857025622 | Non-Tapered Driver Size 20 |
| 10888857025615 | Torque Handle Size 20 in-lbs (2.3 N-m) |
| 10888857025585 | Tap Size 20 mm |
| 10888857025554 | Tapered Driver Size 20 |
| 10888857025547 | Drill Size Ø5.5x20 mm |
| 10888857025530 | Awl Size 20 mm |
| 10888857025516 | Universal Awl Size 25 mm |
| 10888857025509 | Universal Awl Size 20 mm |
| 10888857025493 | Universal Tapered Driver Size 20 |
| 10888857025462 | Modular Tip Assembly |
| 10888857025455 | Inner Shaft Assembly |
| 10888857383494 | Universal Driver Size 20 |
| 10888857297296 | Distractor Size 21 mm |
| 10888857297289 | Distractor Size 19 mm |
| 10888857297272 | Distractor Size 17 mm |
| 10888857297265 | Distractor Size 15 mm |
| 10888857297258 | Distractor Size 13 mm |