SPINAL SURGERY FRAME
FDA 510(k) clearance K875291 · decided 1988-01-22
Clearance details
- K-number
- K875291
- Device name
- SPINAL SURGERY FRAME
- Applicant
- T. Korossurgical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-30
- Decision date
- 1988-01-22
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- BWN
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Moorepark, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch T. Korossurgical Instruments Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AIRFRAME SURGICAL DRAPE SUPPORT (K942699) | Alpha Surgical, Inc. | 1994-07-13 |
| INFINITECH BREATH EZ (K935441) | Infinitech, Inc. | 1994-02-07 |
| ISI SELF-SUPPORTING ARM (K925005) | Instrumentation Specialties, Inc. | 1993-04-29 |
| HOLDER, PEDIATRIC POSITION (K922288) | Yamashita and Hemsley Business Trust | 1993-02-10 |
| SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (K910783) | Smith & Nephew Equipment Group | 1991-04-02 |
| BAUMER SURGICAL TABLE (K902865) | Sds Dental, Inc. | 1990-09-10 |
| IOP ADJUSTABLE STIRRUP (K884558) | Mend Technologies, Inc. | 1988-11-17 |
| ENDOSCOPY TABLE 1532 ENDOSTAR (K873272) | Stierlen-Maquet AG | 1987-09-08 |
| ALLEN UNIVERSAL STIRRUP (K860177) | Edgewater Medical Equipment Systems | 1986-02-11 |
| TABLE ACCESSORIES, OPERATING ROOM (K852332) | Scholten Surgical Instruments, Inc. | 1985-07-02 |
| GUIDE TO THE KNEE (K843121) | Dyonics, Inc. | 1984-09-07 |
| OPERATING ROOM TABLES HYDRAULIC (K832340) | Kamiya Tsusan Kaisha, Ltd. | 1983-08-12 |
Recalls involving this device
No recalls on record reference this clearance.