510(k) K832686
- Device
- MULTIPLE MANUAL SURGICAL INSTRUMENTS
- Applicant
- HIRATA SANGYO CO. USA, INC.
- 510(k) number
- K832686
- Product code
- HTO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-14
- Date received
- 1983-08-02
- Regulation
- 888.4540
- Classification name
- Reamer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1833920
- 9681642
- 3015231789
- 9710524
- 1000517406
- 3010047402
- 3014967969
- 3015882686
- 3008864603
- 1226544
- 3010646402
- 3009417901
- 3005983700
- 3004371426
- 3002719998
- 3009546990
- 3038503932
- 3015167917
- 3014262693
- 3006498370
- 3016237080
- 3006721341
- 3009380063
- 9680518
- 3016032497
- 3010162973
- 3008285983
- 3020155054
- 3006513362
- 1835251
- 3002949614
- 3011687221
- 3005575604
- 3012478585
- 3020704423
- 2249615
- 3035708926
- 1643817
- 3007311878
- 3009882675
- 3037407500
- 9611579
- 3012329926
- 9613926
- 3010065126
- 1824199
- 3025603301
- 3038187464
- 8010944
- 3014257776
- 9611390
- 3004552850
- 3008837339
- 1834331
- 3006125668
- 3004638532
- 3010667733
- 1828464
- 3019878714
- 3005273623
- 9614438
- 1219655
- 3009513193
- 3018094310
- 9617297
- 3004142400
- 1038671
- 3009971621
- 1720929
- 3005941719
- 3009241418
- 1417592
- 2027754
- 3010009693
- 8030607
- 3042248499
- 1651252
- 2522206
- 3011874600
- 3007125392
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K954915 | FLEXIBLE INTRAMEDULLARY REAMER | Zimmer, Inc. | 1995-12-28 |
| 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 |
| 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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