510(k) K954915
- Device
- FLEXIBLE INTRAMEDULLARY REAMER
- Applicant
- ZIMMER, INC.
- 510(k) number
- K954915
- Product code
- HTO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-12-28
- Date received
- 1995-10-26
- Regulation
- 888.4540
- Classification name
- Reamer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNNETTE WHITAKER
- Address
- P.O. Box 708 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 1827813
- 2245304
- 3004521401
- 3032391
- 1422572
- 3003541440
- 8010099
- 1020279
- 3009973699
- 3004944585
- 3007420745
- 1833053
- 3005083075
- 3003596442
- 2522206
- 3012863589
- 3027339877
- 3007289093
- 3014302784
- 3016237080
- 3007200272
- 3010045785
- 2249615
- 3004142400
- 1221763
- 1219518
- 3004153896
- 2183785
- 1526439
- 9615765
- 3017980495
- 3003755939
- 2027467
- 1720929
- 1644408
- 3015487912
- 3009158523
- 3011354099
- 3037407500
- 3008864603
- 1833506
- 1828464
- 3006946279
- 3010531060
- 3007125392
- 9616250
- 3002579136
- 3019455
- 1818910
- 3009590742
- 9614438
- 1417592
- 3014023545
- 3000327445
- 3014662844
- 3003694247
- 3021226419
- 3023265483
- 3012966183
- 1000432246
- 3021336182
- 1065595
- 3015167917
- 3002498892
- 3010470577
- 3013043133
- 3012755988
- 1211566
- 3012130008
- 3008837339
- 1522875
- 1836357
- 3003139373
- 2133687
- 1833920
- 3004358587
- 1643817
- 3018094310
- 3030188041
- 3008812560
Source Documents#
Other 510(k) Records For Product Code HTO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) | Synthes (USA) Products, LLC | 2011-08-10 |
| K042899 | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS | Synthes (Usa) | 2005-03-16 |
| K013527 | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | 2001-12-21 |
| K993335 | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM | Synthes (Usa) | 2000-06-12 |
| K903248 | COMBINATION REAMER | Onyx Medical Corp. | 1990-07-30 |
| K885100 | MCCONNELL REAMER GUIDE | Mcconnell Orthopedic | 1989-01-13 |
| K870845 | WARSAW ORTHOPEDIC POINTED REAMER | Warsaw Orthopedic, Inc. | 1987-03-11 |
| K862933 | ABC-1000 SMALL JOINT REAMERS | Instrumentation Industries, Inc. | 1986-08-18 |
| K832686 | MULTIPLE MANUAL SURGICAL INSTRUMENTS | Hirata Sangyo Co. USA, Inc. | 1983-10-14 |
| K811081 | MEDULLARY CANAL SCRAPERS | The Anspach Effort, Inc. | 1981-04-29 |
| K790996 | C.C.F. FEMORAL DEBRIDEMENT PROBE | Depuy, Inc. | 1979-06-27 |
| K790307 | FLEXIBLE REAMER, GUIDE WIRE SYSTEM | 3M Company | 1979-02-22 |
| K770203 | HAND REAMERS | Depuy, Inc. | 1977-02-08 |
Legacy Summary#
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FDA Review#
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