ARTHROSCOPY SYSTEM LEG HOLDER
FDA 510(k) clearance K821029 · decided 1982-04-29
Clearance details
- K-number
- K821029
- Device name
- ARTHROSCOPY SYSTEM LEG HOLDER
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-13
- Decision date
- 1982-04-29
- Days to decision
- 16 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
- Mchenry, IL, 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |