SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
FDA 510(k) clearance K880188 · decided 1988-03-01
Clearance details
- K-number
- K880188
- Device name
- SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-15
- Decision date
- 1988-03-01
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- JDB
- Device class
- 2
- Regulation number
- 888.3160
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TEMA Elbow system - Line extension (K222807) | Lima Corporate S.P.A. | 2022-10-26 |
| LATITUDE EV™ Total Elbow Arthroplasty (K193247) | Tornier, Inc. | 2020-08-05 |
| LATITUDE EV Total Elbow Arthroplasty (K182461) | Tornier, Inc. | 2018-12-27 |
| Latitude EV Total Elbow Arthroplasty (K171010) | Tornier, Inc. | 2017-08-31 |
| RHEAD RADIAL HEAD EXTENDED STEMS (K102180) | Small Bone Innovations, Inc. | 2010-12-20 |
| LATITUDE ELBOW PROSTHESIS (K100562) | Tornier, Inc. | 2010-06-29 |
| LATITUDE ELBOW PROTHESIS (K070787) | Tornier | 2007-08-24 |
| SBI LATERAL RADIO CAPITELLUM (K070236) | Small Bone Innovations, Inc. | 2007-02-21 |
| RHS (K060438) | Tornier | 2006-04-18 |
| SBI RADIO-CAPITELLAR IMPLANT (K060038) | Small Bone Innovations, Inc. | 2006-03-30 |
| TORNIER ELBOW PROSTHESIS (K050848) | Tornier | 2005-07-14 |
| MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS (K031218) | Tornier | 2003-05-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |