MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
FDA 510(k) clearance K871717 · decided 1987-06-05
Clearance details
- K-number
- K871717
- Device name
- MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-04
- Decision date
- 1987-06-05
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- HWE
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch KARL STORZ Endoscopy-America
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IntelliSense Drill (K143191) | Mcginley Innovations | 2015-02-20 |
| ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (K102743) | Ortho Solutions Limited | 2011-01-20 |
| SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (K063688) | The Anspach Effort, Inc. | 2007-01-16 |
| EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (K050766) | Zimmer Trabecular | 2005-05-26 |
| SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (K043310) | Synthes (Usa) | 2005-01-05 |
| REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K022744) | Medical Device Services | 2002-09-18 |
| REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (K012676) | Adven Medical | 2002-02-04 |
| REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K012694) | Adven Medical | 2002-02-04 |
| AVCORE SYSTEM (K990816) | Modular Cutting Systems, Inc. | 1999-09-24 |
| AESCULAP HILAN MOTOR SYSTEM (K973736) | Aesculap, Inc. | 1997-12-29 |
| BONE GRAFT HARVESTER (K973560) | Ds Mfg., Inc. | 1997-11-12 |
| SURGICAL BURS AND SURGICAL DRILL BITS (K972508) | Synvasive Technology, Inc. | 1997-08-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |