SCHOLTEN FRAME
FDA 510(k) clearance K900405 · decided 1990-03-01
Clearance details
- K-number
- K900405
- Device name
- SCHOLTEN FRAME
- Applicant
- Scholten Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-29
- Decision date
- 1990-03-01
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- JEB
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Oakland, CA, 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 |
|---|---|---|
| ORTHOVISION TABLE (K905816) | American Sterilizer Co. | 1991-03-06 |
| ORTHO-J, INC. BEK-JS-004 (K891917) | Ortho-J, Inc. | 1989-05-26 |
| WILLIAMS BELT & BOOT (K891387) | Arthro-Medic, Inc. | 1989-05-23 |
| K ORTHOPEDIC TABLE (K881101) | Instrumentation Specialties, Inc. | 1988-04-06 |
| OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION (K880263) | Orthopedic Systems, Inc. | 1988-03-15 |
| PLASTER TABLE 1418 (K873274) | Stierlen-Maquet AG | 1987-09-17 |
| EXTENSION DEVICE 1416 (K873276) | Stierlen-Maquet AG | 1987-09-17 |
| EXTENSION TABLE 1417 (K873275) | Stierlen-Maquet AG | 1987-09-17 |
| ORTHOPAEDIC TABLE 1420 (K873273) | Stierlen-Maquet AG | 1987-09-17 |
| CAST BLOCK (K781082) | Orthopedic Equipment Co., Inc. | 1978-07-07 |
| ARTHROSTRESS (K772321) | Mtd, Inc. | 1978-01-03 |
| SPINAL SURGERY FRAME (K771020) | Orthopedic Systems, Inc. | 1977-06-17 |
Recalls involving this device
No recalls on record reference this clearance.