STRYKER KNIFELIGHT
FDA 510(k) clearance K100884 · decided 2010-06-25
Clearance details
- K-number
- K100884
- Device name
- STRYKER KNIFELIGHT
- Applicant
- Howmedica Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-30
- Decision date
- 2010-06-25
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- FTD
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT (K133425) | Engineered Medical Solutions Co., LLC | 2013-12-05 |
| VOLISTA 400; VOLISTA 600 (K130513) | Maquet S.A.S. | 2013-05-08 |
| POLARIS 100/200 (K123776) | Drager Medical GmbH | 2013-03-08 |
| ATRICURE DISSECTOR (K111020) | AtriCure, Inc. | 2011-06-09 |
| HM-LAMP II (K100234) | Hillusa, Inc. | 2010-07-08 |
| SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 (K071180) | Engineered Medical Solutions Co., LLC | 2007-06-20 |
| HALUX IRIS EXAMINATION AND SURGICAL LAMP (K053364) | Waldmann Lighting | 2006-02-23 |
| ATRICURE DISSECTOR (K041681) | AtriCure, Inc. | 2004-07-01 |
| AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (K013242) | STERIS Corporation | 2001-12-13 |
| SOLA 700,SOLA 500, SOLA 300 (K010724) | Drager Medizintechnik GmbH | 2001-06-07 |
| ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 (K003423) | St. Francis Medical Equipment Co., Ltd. | 2001-02-22 |
| STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR (K981717) | Stryker Instruments | 1998-06-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027) | Howmedica Osteonics Corp. | 2025-09-17 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S026) | Howmedica Osteonics Corp. | 2025-05-23 |
| Trident® Acetabular System (P000013/S025) | Howmedica Osteonics Corp. | 2024-03-08 |
| Trident(R), ABC(R) (P000013/S024) | Howmedica Osteonics Corp. | 2024-01-23 |
| Trident Ceramic System (P000013/S021) | Howmedica Osteonics Corp. | 2023-12-20 |
| Trident(R), ABC(R) (P000013/S023) | Howmedica Osteonics Corp. | 2023-12-19 |
| Trident®, ABC® (P000013/S022) | Howmedica Osteonics Corp. | 2023-09-27 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S020) | Howmedica Osteonics Corp. | 2022-04-01 |