HUMERAL LOCKING NAIL SYSTEM
FDA 510(k) clearance K883882 · decided 1989-01-30
Clearance details
- K-number
- K883882
- Device name
- HUMERAL LOCKING NAIL SYSTEM
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-13
- Decision date
- 1989-01-30
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- JDS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Howmedica Corp.
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 |
|---|---|---|
| TRIGEN Stable Lock Nut & Washer (K243608) | Smith & Nephew, Inc. | 2025-06-12 |
| TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System (K240061) | Smith & Nephew, Inc. | 2024-09-20 |
| TRIGEN INTERTAN 10S Nail System (K241804) | Smith & Nephew, Inc. | 2024-08-22 |
| NET BRAND Osteosynthesis Nailing System (K233150) | Narang Medical , Ltd. | 2024-02-20 |
| TRIGEN META-NAIL Nail System (K230761) | Smith & Nephew, Inc. | 2023-06-14 |
| DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm (K201336) | Synthes (USA) Products, LLC | 2020-09-03 |
| Auxein Nailing System (K192003) | Auxein Medical Private Limited | 2020-06-10 |
| WIN Flexible Nail System (K193533) | Biomet, Inc. | 2020-02-20 |
| CONVENTUS PHS SYSTEM (K141737) | Conventus Orthopaedics, Inc. | 2015-04-08 |
| CHINA NAILS AND ACCESSORIES (K123948) | Smith & Nephew, Inc. | 2013-03-14 |
| SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (K111667) | Synthes (Usa) | 2011-12-05 |
| CONNEXX LOCKING TIBIA NAIL (K080706) | I.T.S. Implantat-Technologie-Systeme GmbH | 2008-06-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |