Alta Fully Threaded Cross-Locking 5.0 MM Screw
FDA 510(k) K993004 · Howmedica Osteonics Corp.
510(k) numberK993004
Submission
- Device name
- Alta Fully Threaded Cross-Locking 5.0 MM Screw
- Applicant
- Howmedica Osteonics Corp.
Rutherford, NJ, US - Received
- September 7, 1999
- Decision date
- October 6, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDS – Nail, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K193533 | WIN Flexible Nail SystemJDS · Traditional | Biomet, Inc. | 02/20/2020SE |
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| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…JWH · Traditional | 02/14/2013SE |
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Questions and answers
When was Alta Fully Threaded Cross-Locking 5.0 MM Screw cleared by the FDA?
Alta Fully Threaded Cross-Locking 5.0 MM Screw (K993004) received a 510(k) decision of Substantially Equivalent on October 6, 1999, 29 days after the submission was received.
What is the product code of K993004?
The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.