ZIMMER SKIN PROTECTOR
FDA 510(k) clearance K830287 · decided 1983-03-09
Clearance details
- K-number
- K830287
- Device name
- ZIMMER SKIN PROTECTOR
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-27
- Decision date
- 1983-03-09
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- GAD
- Device class
- 1
- Regulation number
- 878.4800
- 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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| QUADRANT RETRACTOR SYSTEM (K043602) | Medtronic Sofamor Danek | 2005-02-23 |
| MRI FASTSYSTEM RETRACTOR SYSTEM (K001339) | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 |
| CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (K980588) | Clarus Medical Systems, Inc. | 1998-08-18 |
| SCION SAPHENOUS VEIN HARVESTING SYSTEM (K963006) | Scion International, Inc. | 1996-09-20 |
| VILLALTA RETRACTOR (K943875) | Hct, Inc. | 1994-11-09 |
| RETRACTOR (K942002) | Automated Medical Products Corp. | 1994-05-17 |
| RETRACTOR (K941448) | Technovations | 1994-04-15 |
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 |