510(k) K173391
- Device
- OsteoMed QuickFix Hybrid MMF Sterilization Tray
- Applicant
- OsteoMed LLC
- 510(k) number
- K173391
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-10
- Date received
- 2017-10-30
- Regulation
- 880.6850
- Classification name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jessica M. Ruperto
- Address
- 3885 Arapaho Rd. Addison TX US 75001 75001
FDA Registration Numbers#
- 8040233
- 3012236936
- 3008812560
- 3009307953
- 3004203816
- 3004080920
- 1314417
- 1450428
- 8030674
- 3008517893
- 3013177549
- 3011577940
- 3014553709
- 2518634
- 2919128
- 3007695749
- 9680718
- 3005706667
- 3005497913
- 3015895045
- 8010099
- 9611102
- 1836161
- 3008868758
- 3011795235
- 3020767943
- 1828464
- 3005694091
- 1221763
- 2936485
- 3002259632
- 3006008984
- 1423662
- 9613277
- 3004153240
- 3043237009
- 1221934
- 3004976965
- 3026612481
- 1935627
- 3043164947
- 1418479
- 3005004799
- 3006113180
- 3015960676
- 9680735
- 2132732
- 9612468
- 3038718579
- 3013357025
- 1923569
- 1017294
- 9617542
- 3007367732
- 9610773
- 2020550
- 3008864603
- 3014409963
- 3011533888
- 3010041430
- 8044099
- 9681851
- 3008252251
- 3010141593
- 3009540749
- 3014421917
- 3004201263
- 3007389669
- 3004215117
- 3005741909
- 3009539885
- 3005409899
- 9613348
- 3009538923
- 9680845
- 1421879
- 3010120135
- 3018094310
- 3021119558
- 1056553
Source Documents#
Other 510(k) Records For Product Code KCT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026-06-18 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026-06-03 |
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 |
| K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid | DePuy Mitek, Inc. | 2026-02-26 |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026-02-06 |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | 2025-11-14 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025-07-22 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | 2025-06-20 |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025-05-13 |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025-05-01 |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025-03-28 |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) | Prismatik Dentalcraft, Inc. | 2025-03-21 |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | 2025-02-19 |
| K243317 | NUVENTUS NV.C™ Surgical Cassette and Tray | Infinitum Eta, Ltd. | 2025-02-11 |
Legacy Summary#
summary
FDA Review#
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