510(k) K770203
- Device
- HAND REAMERS
- Applicant
- DEPUY, INC.
- 510(k) number
- K770203
- Product code
- HTO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-08
- Date received
- 1977-01-31
- 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#
- 3016851379
- 3008583793
- 3007289093
- 8010379
- 3007882731
- 2133687
- 3004464325
- 3013055499
- 3007125392
- 3005273623
- 3004358587
- 3007366790
- 3013156185
- 3011015572
- 8010099
- 3004638532
- 3014257776
- 3034525
- 1833053
- 3014314623
- 1221934
- 3021519357
- 3021226419
- 1835998
- 3011495120
- 3007441485
- 3042508254
- 2011171
- 1423662
- 2133928
- 3009882675
- 1043534
- 3011210208
- 3006128100
- 3009106092
- 3009590742
- 3009973699
- 3037407500
- 2031093
- 3008770252
- 3015183635
- 3005677016
- 3008650117
- 3008787426
- 3005751028
- 1211566
- 3005180920
- 1522875
- 9611390
- 3009732568
- 9616944
- 8010944
- 3006638824
- 3010057495
- 3017521423
- 3038187464
- 3009417901
- 3008850074
- 3020584246
- 3018094310
- 3013194153
- 3003139373
- 3010531060
- 3010123256
- 2134285
- 3002498892
- 3020704423
- 3012523063
- 2132732
- 3016438694
- 3038195984
- 3012755988
- 1651252
- 2183449
- 3021477808
- 1824199
- 3005596514
- 3037027197
- 9611283
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 |
| 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 |
Legacy Summary#
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FDA Review#
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