FDA Registration
Active
🇺🇸 United States
Stryker Sustainability Solutions Lakeland
Reg #: 1056128
·
FEI: 1000132435
·
Expires 2026
Products
9
Proprietary Names
32
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- Stryker Sustainability Solutions Lakeland
- Registration Number
- 1056128
- FEI Number
- 1000132435
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5307 Great Oak Drive
- City
- LAKELAND
- State
- FL
- ZIP
- 33815
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180451
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-04-20 |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | Class 2 | General, Plastic Surgery | No | 2018-04-20 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2010-02-05 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2020-10-05 |
| Laparoscope, General & Plastic Surgery, Reprocessed | NLM | Class 2 | Gastroenterology, Urology | No | 2010-07-23 |
| Single-Use Reprocessed Ultrasonic Surgical Instruments | NLQ | Class U | Unknown | No | 2024-02-26 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2024-02-26 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2010-02-05 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2016-05-10 |
Proprietary Names
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
Reprocessed Arthroscopic Cutters
Reprocessed MyoSure XL Tissue Removal Device
Reprocessed MyoSure LITE Tissue Removal Device
Reprocessed MyoSure XL Tissue Removal Device for Fluent
Reprocessed MyoSure Tissue Removal Device
Reprocessed MyoSure REACH Tissue Removal Device
Reprocessed Endoscopic Instruments
Reprocessed Trocars
Remanufactured LigaSure Exact Dissector, Without Nano-coating
Reprocessed HARMONIC HAR1100 Shears
Reprocessed SERFAS Arthroscopic Cutters
Remanufactured LigaSure Exact Dissector Without Nano-coating
Reprocessed HARMONIC ACE+ 7, 5 Mm Diameter Shears With Advanced Hemostasis
Reprocessed Ultrasonic Scalpel
Reprocessed Suture Passer
Reprocessed Arthroscopic Wands
Reprocessed Electrosurgical Laparoscopic Endoscoipic Instruments
Reprocessed LigaSure Maryland Jaw Sealer/Divider
Reprocessed HARMONIC 1100 Shears
Reprocessed Unipolar Laparoscopic/Endoscopic Instruments
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider
Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Dividers
Reprocessed Laparoscopic Accessories
Reprocessed HARMONIC 700 Shears
Reprocessed Harmonic ACE+7, 5mm Diameter Shears with Advanced Hemostasis
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Reprocessed Arthroscopic Wand
Reprocessed Trocars and Stability Sleeves
Reprocessed Harmonic ACE Shears without adaptive tissue technology
Reprocessed Blunt Tip Laparoscopic Sealer/Divider
Reprocessed Endoscopic Trocars and Sleeves
Establishment Types
Reprocess Single-Use Device
Remanufacture Medical Device