Company · US
Nuvasive Specialized Orthopedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (1 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2026 | K261651 | Precice Max System and Precice Ankle Salvage System NuVasive Specialized Orthopedics | HSB |
| Feb 6, 2024 | K233593 | MAGEC Spinal Bracing and Distraction System Nuvasive Specialized Orthopedics, Incorporated | PGN |
| Dec 15, 2023 | K232267 | Precice Max System Nuvasive Specialized Orthopedics, Incorporated | HSB |
| Aug 29, 2023 | K230765 | Precice Ankle Salvage System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Mar 15, 2023 | K220234 | Precice Intramedullary Limb Lengthening System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Dec 22, 2020 | K202348 | External Remote Controller ERC 4P Nuvasive Specialized Orthopedics, Inc. | HSB |
| Sep 16, 2020 | K200430 | Precice® Ankle Salvage System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Aug 10, 2020 | K201567 | Precice® Bone Transport System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Jul 30, 2020 | K201543 | MAGEC® System Nuvasive Specialized Orthopedics, Inc. | PGN |
| May 8, 2020 | K193617 | Precice® Screws Nuvasive Specialized Orthopedics, Inc. | HSB |
| May 8, 2020 | K193016 | PRECICE Bone Transport System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Nov 7, 2019 | K192181 | PRECICE Plating System Nuvasive Specialized Orthopedics, Inc. | KTT |
| Sep 26, 2019 | K191336 | PRECICE System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Feb 5, 2019 | K182170 | PRECICE® BONE TRANSPORT System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Apr 3, 2018 | K180503 | PRECICE STRYDE System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Dec 1, 2017 | K173129 | PRECICE System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Sep 25, 2017 | K172628 | PRECICE System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Aug 31, 2017 | K171791 | MAGEC® System Nuvasive Specialized Orthopedics, Incorporated | PGN |
| Aug 24, 2017 | K172061 | PRECICE UNYTE System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Aug 8, 2017 | K170939 | Supplemental Instrument Trays Nuvasive Specialized Orthopedics, Incorporated | KCT |
| Jun 9, 2017 | K170169 | PRECICE Intramedullary Limb Lengthening System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Apr 6, 2017 | K162927 | PRECICE UNYTE CoCr System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Mar 7, 2017 | K170346 | PRECICE Intramedullary Limb Lengthening System Nuvasive Specialized Orthopedics, Inc. | HSB |
| Oct 21, 2016 | K160352 | MAGEC® Spinal Bracing and Distraction System Nuvasive Specialized Orthopedics, Inc. | PGN |
| Sep 2, 2016 | K161751 | MAGEC® Spinal Bracing and Distraction System Nuvasive Specialized Orthopedics, Inc. | PGN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2024 | NuVasive Specialized Orthopedics, Inc. Precice Max REF:
PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm
PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm
PM10.0-80B305 PRECICE MA Open, Classified |
HSB | K232267 |
| Dec 14, 2022 | NuVasive Specialized Orthopedics, Inc. NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis.
REF Model Numbers/NSO Item #/Product Description
MC2-4590S / PA0684 Open, Classified |
PGN | K201543 |
| Dec 1, 2021 | NuVasive Specialized Orthopedics, Inc. NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System:
Model Number/Item Number/Product Description:
CPA1-000 PA0382-001 End Cap
CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM Open, Classified |
HSB | K101997 K113695 +2 |
| Apr 5, 2021 | Nuvasive Specialized Orthopedics Inc NUVASIVE FREEDOM:
End Cap for PRECICE Intramedullary Limb Lengthening System Implant;
Packaged End Cap 8.5/10.7mm, +0mm;
Packaged End Cap 8.5/10.7mm, +5mm;
Packaged End Cap 8.5/10.7mm, +10mm;
Package Open, Classified |
HSB | K141739 |
| Apr 5, 2021 | Nuvasive Specialized Orthopedics Inc NUVASIVE PRECICE UNYTE System (Humerus and Tibia):
PRECICE Trauma Nail System/PRECICE Unyte-Humerus
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length;
Orthopedic trauma in Open, Classified |
HSB | K113695 |
| Apr 5, 2021 | Nuvasive Specialized Orthopedics Inc NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System
End Cap for PRECICE Intramedullary Limb Lengthening System Implant;
Packaged End Cap 8.5/10.7mm, +0mm;
Packaged End Cap 8.5/ Open, Classified |
HSB | K101997 K151131 |
| Mar 30, 2021 | Nuvasive Specialized Orthopedics Inc PRECICE PLATE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. Open, Classified |
HSB | K192181 |
| Mar 30, 2021 | Nuvasive Specialized Orthopedics Inc Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. Open, Classified |
HSB | K182170 K201567 |
| Mar 30, 2021 | Nuvasive Specialized Orthopedics Inc PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. Open, Classified |
HSB | K180503 |
| Jul 24, 2020 | Nuvasive Specialized Orthopedics Inc NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend
Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screw Open, Classified |
HSB | K193016 K201567 |
| Jun 25, 2019 | NuVasive Specialized Orthopedics, Inc. MAGEC 1 System Open, Classified |
PGN | K140178 |