SHAMPAINE RADI-OP MODEL 1700RC
FDA 510(k) clearance K860620 · decided 1986-04-08
Clearance details
- K-number
- K860620
- Device name
- SHAMPAINE RADI-OP MODEL 1700RC
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-19
- Decision date
- 1986-04-08
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- KXJ
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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| CAG-02A (K922098) | Toshiba America Medical Systems, In.C | 1992-07-27 |
| OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 (K913121) | Continental X-Ray Corp. | 1991-08-16 |
| RADKOR, RF-159 (K883885) | Radkor, Inc. | 1988-10-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |