Custom Orthopaedic Trays (Packs)
FDA 510(k) K930507 · Associated Medical Products Co.
510(k) numberK930507
Submission
- Device name
- Custom Orthopaedic Trays (Packs)
- Applicant
- Associated Medical Products Co.
St. Louis Park, MN, US - Received
- February 1, 1993
- Decision date
- February 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HTS – Knife, Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933921 | Acuflex Disposable KnivesHTS · Traditional | Acufex Microsurgical, Inc. | 01/26/1994SE |
| K882525 | Spinal MicroknifeHTS · Traditional | Karlin Technology, Inc. | 09/22/1988SE |
| K873714 | Banana Knife, Disposable #TM-1612HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873713 | Triangular Knife, Disposable #TM-1611HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873711 | Retrograde Knife, Disposable #TM-1613HTS · Traditional | Arthropedics, Inc. | 11/02/1987SE |
| K873712 | Standard Knife, Disposable #TM-1610HTS · Traditional | Arthropedics, Inc. | 10/15/1987SE |
| K842820 | Arthroscopy KnivesHTS · Traditional | Medtech Industries, Inc. | 08/14/1984SE |
| K771851 | Arthroscope Operative Knife SetHTS · Traditional | Richard Wolf Medical Instruments Corp. | 10/27/1977SE |
More from Richard Wolf Medical Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | 03/19/1997SE |
| K932216 | C-Section, Labor & Delivery Trays (Packs)MLS · Traditional | 04/19/1994SESK |
| K932217 | Major, Minor, Basin Trays (Packs)LRO · Traditional | 11/15/1993SESK |
| K932220 | Lap Choly Trays (Packs)LRO · Traditional | 09/27/1993SESK |
| K932218 | Cardiac Cath or Angiographic TraysDQO · Traditional | 08/27/1993SEKD |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | 07/09/1993SESK |
| K842983 | Ampco Opthalmic TrayHOZ · Traditional | 05/22/1985SE |
| K843114 | Ampco Procedure Trays / Packs · Traditional | 08/08/1984SESP |
| K823839 | Ampco Kidney Dialysis TrayKOC · Traditional | 03/29/1983SE |
| K821579 | Skin Scrub-TrayLDR · Traditional | 07/21/1982SE |
Questions and answers
When was Custom Orthopaedic Trays (Packs) cleared by the FDA?
Custom Orthopaedic Trays (Packs) (K930507) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 386 days after the submission was received.
What is the product code of K930507?
The FDA product code is HTS – Knife, Orthopedic, a Class I (low risk) device regulated under 21 CFR 888.4540.