EDWARDS SACRAL SCREW
FDA 510(k) clearance K851935 · decided 1985-06-07
Clearance details
- K-number
- K851935
- Device name
- EDWARDS SACRAL SCREW
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-06
- Decision date
- 1985-06-07
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- KWP
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, 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 |
|---|---|---|
| LnK Posterior Cervical Fixation System (K143278) | L&K BIOMED Co., Ltd. | 2015-07-29 |
| OASYS System (K150753) | Stryker Corporation | 2015-06-09 |
| Sure Lok Mini Posterior Cervical/Upper Thoracic System (K150851) | Precision Spine, Inc. | 2015-06-04 |
| Reliance Posterior Cervical-Thoracic System (K142867) | Reliance Medical Systems, LLC | 2015-04-29 |
| Streamline OCT Occipito-Cervico-Thoracic System (K150254) | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-04-28 |
| SOLSTICE OCT System (K142253) | Life Spine, Inc. | 2015-04-23 |
| SOLSTICE OCT System (K150229) | Life Spine, Inc. | 2015-04-07 |
| SOLSTICE OCT System (K143249) | Life Spine, Inc. | 2015-04-07 |
| OASYS System (K142741) | Stryker Corporation | 2015-01-15 |
| Caspian OCT/MESA Mini/DENALI Mini Spinal System (K142558) | K2m | 2014-12-22 |
| NEXTGEN ALTIUS OCT SYSTEM (K140734) | Ebi, LLC | 2014-12-15 |
| EXPEDIUM Spine System/Synapse System (K142460) | Johnson and Johnson | 2014-10-01 |
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 |