STRYKER TOTAL PERFORMANCE SYSTEM
FDA 510(k) clearance K943589 · decided 1994-12-15
Clearance details
- K-number
- K943589
- Device name
- STRYKER TOTAL PERFORMANCE SYSTEM
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-22
- Decision date
- 1994-12-15
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- HWE
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Portage, MI, US
- Third-party review
- No
- Expedited review
- No
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| REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K022744) | Medical Device Services | 2002-09-18 |
| REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (K012676) | Adven Medical | 2002-02-04 |
| REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K012694) | Adven Medical | 2002-02-04 |
| AVCORE SYSTEM (K990816) | Modular Cutting Systems, Inc. | 1999-09-24 |
| AESCULAP HILAN MOTOR SYSTEM (K973736) | Aesculap, Inc. | 1997-12-29 |
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| SURGICAL BURS AND SURGICAL DRILL BITS (K972508) | Synvasive Technology, Inc. | 1997-08-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |