ORHTOPEDIC REAMER 87 HTD
FDA 510(k) clearance K802676 · decided 1980-11-12
Clearance details
- K-number
- K802676
- Device name
- ORHTOPEDIC REAMER 87 HTD
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-29
- Decision date
- 1980-11-12
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- HTD
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE NEEDLE CATCHER (K051281) | E.D.Medical , Ltd. | 2005-09-08 |
| SEMKIN BIPOLAR FORCEP (K974594) | Titan Mfg., Inc. | 1998-06-24 |
| CUSHING BAYONET, INSULATED BIPOLAR FORCEP (K974595) | Titan Mfg., Inc. | 1998-06-24 |
| SEMKIN INSULATED BIPOLAR FORCEP (K974593) | Titan Mfg., Inc. | 1998-06-24 |
| MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (K913964) | Marlo Surgical Technology | 1991-10-23 |
| CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS (K911180) | Northgate Technologies, Inc. | 1991-03-29 |
| TIK EXTRAKTOR (K895212) | Instruments of Sweden, Inc. | 1989-09-27 |
| HEMORRHOIDAL FORCEPS (K890373) | Kinetic Medical Products | 1989-02-03 |
| GALL STONE FORCEPS (K890369) | Kinetic Medical Products | 1989-02-03 |
| TUBING CLAMP FORCEPS (K890244) | Kinetic Medical Products | 1989-01-27 |
| BONE CUTTING FORCEPS, SINGLE-ACTION (K890258) | Kinetic Medical Products | 1989-01-27 |
| LUNG FORCEPS (K890262) | Kinetic Medical Products | 1989-01-27 |
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 |