510(k) K951860
- Device
- HOWMEDICE BONE PLUG
- Applicant
- HOWMEDICA CORP.
- 510(k) number
- K951860
- Product code
- LZN
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1995-05-16
- Date received
- 1995-04-21
- Regulation
- 878.3300
- Classification name
- Cement Obturator
- Medical specialty
- General & Plastic Surgery
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY C SPICER
- Address
- 359 Veterans Blvd. Rutherford NJ US 07070 07070
FDA Registration Numbers#
- 3007366790
- 2242737
- 9616680
- 2648623
- 2245304
- 3004748528
- 2649614
- 3000196378
- 1818910
- 8010379
- 1047843
- 1450662
- 3038503932
- 3015967359
- 1526711
- 1649518
- 3008337808
- 3000931034
- 3008110533
- 3021008900
- 1423662
- 3013176080
- 2648920
- 3002907620
- 3002807295
- 3010370500
- 3015207155
- 1020279
- 3035366890
- 3008868758
- 9610726
- 1526350
- 1018470
- 3016678045
- 3015173212
- 2249697
- 3005180920
- 1220477
- 3010173425
- 3015516266
- 3036756245
- 3005581234
- 1526534
- 3010178296
- 3010536692
- 3025603301
- 3006356043
- 2648666
- 3013014058
- 3033509898
- 1822565
- 9615788
- 3008744062
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220838 | Artisan Bone Plug, Universal Cement Restrictor | Howmedica Osteonics, Dba Stryker Orthopaedics | 2022-05-20 |
| K061824 | TORNIER CEMENT RESTRICTOR | Tornier | 2006-09-14 |
| K032685 | CEMSTOP CEMENT RESTRICTOR | Teknimed, S.A. | 2003-11-26 |
| K023680 | BIOBUCK CEMENT RESTRICTOR | Smith & Nephew, Inc. | 2002-11-19 |
| K011943 | IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR | Kensey Nash Corp. | 2001-09-19 |
| K010840 | SYNPLUG | Isotis NV | 2001-04-20 |
| K993841 | CEMSTOP CEMENT RESTRICTOR | Encore Orthopedics, Inc. | 2000-05-04 |
| K000587 | SHUTTLE STOP | Isotis NV | 2000-05-04 |
| K992462 | OSTEONICS UNIVERSAL DISTAL CEMENT PLUG | Howmedica Osteonics Corp. | 1999-08-13 |
| K972411 | LINK CEMENT PLUG | Turnkey Intergration USA, Inc. | 1997-08-29 |
| K970779 | OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS | Osteonics Corp. | 1997-05-09 |
| K955632 | ORTHOPLUG SOFT BONE DESIGN | Sunmed, Inc. | 1996-02-27 |
| K955631 | ORTHOPLUG HARD BONE DESIGN | Sunmed, Inc. | 1996-02-27 |
| K955751 | PRIME FEMORAL CEMENT PLUG | Orthopaedic Innovations, Inc. | 1996-01-26 |
| K951930 | CEMENTRALIZER DISTAL STEM CENTRALIZER | Depuy, Inc. | 1995-07-11 |
Legacy Summary#
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FDA Review#
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