Product code HTO
- Device name
- Reamer
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K770203 | HAND REAMERS | Depuy, Inc. | 1977-02-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190376544502 | Invictus | ALPHATEC SPINE, INC. | 2026-07-30 |
| 03701089526364 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089526371 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03701089526388 | AMPLITUDE | AMPLITUDE SAS | 2026-07-29 |
| 03700569676636 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-28 |
| 03700569676643 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-28 |
| 03700569676650 | Newclip Instruments | NEWCLIP TECHNICS | 2026-07-28 |
| 18059015378320 | Flexible Reamers System | ORTHOFIX SRL | 2026-07-23 |
| 18059015378337 | Flexible Reamers System | ORTHOFIX SRL | 2026-07-23 |
| 18059015378344 | Flexible Reamers System | ORTHOFIX SRL | 2026-07-23 |
| 18059015378351 | Flexible Reamers System | ORTHOFIX SRL | 2026-07-23 |
| 18059015378399 | Flexible Reamers System | ORTHOFIX SRL | 2026-07-23 |
| 10810128461464 | Back Drill 4.5 X 9.0mm | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-07-22 |
| 10810128463338 | Back Drill 6.0 X 11.0mm | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-07-22 |
| 10810128461488 | Back Drill 4.5 X 10.0mm | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-07-22 |
| 10810128461471 | Back Drill 4.5 x 9.5mm | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-07-22 |
| 10810128461457 | Back Drill 4.5 X 8.5mm | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-07-22 |
| 10810128461440 | Back Drill 4.5 X 8.0mm | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-07-22 |
| 10810128461426 | Back Drill 4.5 X 7.0mm | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2026-07-22 |
| 00889024710580 | Custom Femoral Lateralizing Reamer | Zimmer, Inc. | 2026-07-20 |
| B504OMAR14510 | Arthrex | Provision | 2026-07-20 |
| 00888867457782 | Arthrex® | ARTHREX, INC. | 2025-11-28 |
| 00888867444966 | Arthrex® | ARTHREX, INC. | 2025-10-24 |
| 00841132131916 | General Instrument | ORTHOPEDIATRICS CORP. | 2016-10-31 |
| 00841132131923 | General Instrument | ORTHOPEDIATRICS CORP. | 2016-10-31 |
| 00841132131930 | General Instrument | ORTHOPEDIATRICS CORP. | 2016-10-31 |
| 00841132131947 | General Instrument | ORTHOPEDIATRICS CORP. | 2016-10-31 |
| 00841132131954 | General Instrument | ORTHOPEDIATRICS CORP. | 2016-10-31 |
| 00841132131961 | General Instrument | ORTHOPEDIATRICS CORP. | 2016-10-31 |
| 00841132131978 | General Instrument | ORTHOPEDIATRICS CORP. | 2016-10-31 |