Interference Screw
FDA 510(k) K943160 · Applied Osteo Systems, Inc.
510(k) numberK943160
Submission
- Device name
- Interference Screw
- Applicant
- Applied Osteo Systems, Inc.
Walnut Creek, CA, US - Received
- July 1, 1994
- Decision date
- September 30, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935383 | Femrod and Femrod Recon InsertHSB · Traditional | 03/21/1995SE |
| K933995 | True/Flextm Femur Rods, Caps, Screws and InstrumentationHSB · Traditional | 01/27/1995SE |
| K944501 | True/Flex Intramedullary Rod End-CapHSB · Traditional | 11/28/1994SE |
| K941048 | True/Lok Monolateral/Bilateral FixatorLXT · Traditional | 10/03/1994SE |
| K934148 | True/Flex Clavicle RodsHSB · Traditional | 02/22/1994SE |
| K932853 | Pin Holders, Transfixing Pins, Ol Wires, Half PinsJEL · Traditional | 02/22/1994SE |
| K931578 | Texas Scottish Rite Easy/Lock FixatorJEC · Traditional | 02/22/1994SE |
| K926465 | Femoral Intramedullary RodsJDS · Traditional | 08/25/1993SE |
| K924657 | True/Flex Metatarsal RodsKTW · Traditional | 11/24/1992SE |
| K924656 | True/ Flex Fibula RodsHSB · Traditional | 11/24/1992SE |
Questions and answers
When was Interference Screw cleared by the FDA?
Interference Screw (K943160) received a 510(k) decision of Substantially Equivalent for Some Indications on September 30, 1994, 91 days after the submission was received.
What is the product code of K943160?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.