OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
FDA 510(k) clearance K992462 · decided 1999-08-13
Clearance details
- K-number
- K992462
- Device name
- OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
- Applicant
- Howmedica Osteonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-23
- Decision date
- 1999-08-13
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- LZN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Allendale, NJ, 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 |
|---|---|---|
| Artisan Bone Plug, Universal Cement Restrictor (K220838) | Howmedica Osteonics, Dba Stryker Orthopaedics | 2022-05-20 |
| TORNIER CEMENT RESTRICTOR (K061824) | Tornier | 2006-09-14 |
| CEMSTOP CEMENT RESTRICTOR (K032685) | Teknimed, S.A. | 2003-11-26 |
| BIOBUCK CEMENT RESTRICTOR (K023680) | Smith & Nephew, Inc. | 2002-11-19 |
| IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR (K011943) | Kensey Nash Corp. | 2001-09-19 |
| SYNPLUG (K010840) | Isotis NV | 2001-04-20 |
| CEMSTOP CEMENT RESTRICTOR (K993841) | Encore Orthopedics, Inc. | 2000-05-04 |
| SHUTTLE STOP (K000587) | Isotis NV | 2000-05-04 |
| LINK CEMENT PLUG (K972411) | Turnkey Intergration USA, Inc. | 1997-08-29 |
| OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS (K970779) | Osteonics Corp. | 1997-05-09 |
| ORTHOPLUG SOFT BONE DESIGN (K955632) | Sunmed, Inc. | 1996-02-27 |
| ORTHOPLUG HARD BONE DESIGN (K955631) | Sunmed, Inc. | 1996-02-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System (P000013/S027) | Howmedica Osteonics Corp. | 2025-09-17 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S026) | Howmedica Osteonics Corp. | 2025-05-23 |
| Trident® Acetabular System (P000013/S025) | Howmedica Osteonics Corp. | 2024-03-08 |
| Trident(R), ABC(R) (P000013/S024) | Howmedica Osteonics Corp. | 2024-01-23 |
| Trident Ceramic System (P000013/S021) | Howmedica Osteonics Corp. | 2023-12-20 |
| Trident(R), ABC(R) (P000013/S023) | Howmedica Osteonics Corp. | 2023-12-19 |
| Trident®, ABC® (P000013/S022) | Howmedica Osteonics Corp. | 2023-09-27 |
| Trident Acetabular System: Trident Alumina Inserts (P000013/S020) | Howmedica Osteonics Corp. | 2022-04-01 |