EXETER INTRAMEDULLARY BONE PLUG
FDA 510(k) clearance K933077 · decided 1995-05-16
Clearance details
- K-number
- K933077
- Device name
- EXETER INTRAMEDULLARY BONE PLUG
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1993-06-23
- Decision date
- 1995-05-16
- Days to decision
- 692 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
- Rutherford, 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 |
| OSTEONICS UNIVERSAL DISTAL CEMENT PLUG (K992462) | Howmedica Osteonics Corp. | 1999-08-13 |
| 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 |
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 |