510(k) K885100
- Device
- MCCONNELL REAMER GUIDE
- Applicant
- MCCONNELL ORTHOPEDIC
- 510(k) number
- K885100
- Product code
- HTO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-13
- Date received
- 1988-12-12
- Regulation
- 888.4540
- Classification name
- Reamer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENNIS T GRIGGS
- Address
- Treee Lincoln Centre 5430 Lbj Fwy. Suite 1540 Dallas TX US 75240 75240
FDA Registration Numbers#
- 3014302784
- 1424263
- 3005575604
- 3003596442
- 3023265483
- 9613910
- 3007143290
- 9616246
- 3004552850
- 3030989819
- 3017521423
- 3004358587
- 3002808227
- 3026311512
- 1522875
- 3006513362
- 3035708926
- 3006563559
- 3012130008
- 1833920
- 3010057495
- 1835998
- 3020650900
- 3007882731
- 3015679904
- 3006498370
- 3027339877
- 3012697315
- 3012329926
- 1000517406
- 2031009
- 3008837339
- 3009732568
- 3006125668
- 1833986
- 3010049501
- 3009888740
- 3010646402
- 3011015572
- 3004976965
- 3008110533
- 1720929
- 3010667733
- 3007648354
- 3038195984
- 1828288
- 3015487912
- 1827813
- 3009790163
- 1038671
- 3014314623
- 3008281151
- 3008544874
- 3034676720
- 1020279
- 1226544
- 3005941719
- 1644408
- 3006946279
- 8040278
- 1219655
- 3009106092
- 3013875765
- 3008770252
- 3015399803
- 3004464325
- 9681642
- 3021226419
- 3031240334
- 3006638824
- 3011210208
- 3030531649
- 3016443334
- 3000270450
- 1526439
- 3014207283
- 3010123303
- 3009554293
- 3002498892
- 3006721341
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 |
| 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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