COLLINS POSITIONING DEVICE
FDA 510(k) clearance K864880 · decided 1986-12-29
Clearance details
- K-number
- K864880
- Device name
- COLLINS POSITIONING DEVICE
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-12
- Decision date
- 1986-12-29
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- FWZ
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hayward, 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 |
|---|---|---|
| RETRACTOR ARM CLAMP (K960019) | Biopsys Medical, Inc. | 1996-02-09 |
| 'LIL MAC ACCESSORY CLAMP(TM) (K945415) | D.L. Nelson and Assoc., Inc. | 1994-11-22 |
| CARBON LIGHTS HAND SURGERY TABLE (K944779) | Allen Medical Systems, Inc. | 1994-10-14 |
| KAPS POSITIONING ARM (K935381) | Andronic Devices, Ltd. | 1994-04-15 |
| WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) (K931037) | Whitmore Ent., Inc. | 1993-07-30 |
| SPONGE COUNTER (K926225) | American Medical Manufacturer, Inc. | 1993-03-05 |
| MIDKIFF GEOSTATIC CLAMP (K925035) | D.L. Nelson and Assoc., Inc. | 1993-02-18 |
| PREP AND OPERATING STAND (K905564) | Mcconnell Orthopedic | 1991-02-21 |
| LATERAL BUTTRESS SUPPORT (K905565) | Mcconnell Orthopedic | 1991-02-21 |
| PARK CITY SHOULDER POSITIONER (K910031) | Orthopedic Systems, Inc. | 1991-01-24 |
| TKO TELESCOPING LITHOTOMY STIRRUP (K904826) | D.L. Nelson and Assoc., Inc. | 1990-10-31 |
| LINCOLN MILLS FOOT AND LEG HOLDER (K897028) | Lincoln Mills, Inc. | 1990-01-12 |
Recalls involving this device
No recalls on record reference this clearance.