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#
- 3006561161
- 9614438
- 3027339877
- 3010047454
- 1226544
- 1833986
- 3012995405
- 3014662844
- 3008021110
- 2183785
- 1221934
- 3003477135
- 3012447612
- 3006395932
- 3019878714
- 3030188041
- 3009971621
- 3012104767
- 3013055499
- 3039169546
- 3011307621
- 3013820441
- 3010045785
- 1211566
- 3011274144
- 3017565094
- 3035708926
- 3038503932
- 3018094310
- 3011015572
- 3003525643
- 3006638824
- 3007441485
- 3010370500
- 3012863589
- 3008583793
- 3015167917
- 3029933740
- 1720929
- 3003541440
- 3012523063
- 3006946279
- 3010470577
- 3004142400
- 3016851379
- 1423662
- 3012966183
- 3010531060
- 3006128100
- 3007366790
- 3042508254
- 1828464
- 3006460162
- 3016438694
- 1219518
- 3008864603
- 3019356409
- 3015806723
- 9617297
- 3005596514
- 3036756245
- 8010300
- 3010049501
- 3042248499
- 3009380063
- 3021477808
- 3008787426
- 3010331645
- 9612420
- 3031261833
- 3015876273
- 3006801265
- 3007143290
- 3004638532
- 3014314623
- 3005061536
- 3015179588
- 3009455196
- 3015231789
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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