GUIDE TO THE KNEE
FDA 510(k) clearance K843121 · decided 1984-09-07
Clearance details
- K-number
- K843121
- Device name
- GUIDE TO THE KNEE
- Applicant
- Dyonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-08
- Decision date
- 1984-09-07
- Days to decision
- 30 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| 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 |
| SPINAL SURGERY FRAME (K875291) | T. Korossurgical Instruments Corp. | 1988-01-22 |
| 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 |
| OPERATING ROOM TABLES HYDRAULIC (K832340) | Kamiya Tsusan Kaisha, Ltd. | 1983-08-12 |
Recalls involving this device
No recalls on record reference this clearance.