Devices

Device Recall Stryker AVS Navigator

Model / Serial
Class I; 510(k) Exempt Description: AVS¿ Navigator Trials. Size 6mm -15mm. Catalog Number: 48392206,48392207,48392208,48392209,48392210, 48392211,48392212,48392213,48392214,48392215. Lot Code: 104864,104866, 104867, 104868, 104869, 104870, 10E331, 104871, 104872, 104873, 104874, 104875.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide.
Product Description
Stryker AVS Navigator Trials 6mm-15mm || Manufactured by: || Stryker Spine SAS || Z.1 Marticot-33610-Cestas -France || +33 (0) 5.57.97.06.30 || http;//www.stryker.com || Distributed in the USA by || Stryker Spine || 2 Pearl Court. Allendale || NJ 07401-1677 USA || +1-201-780-8000 || Cestas France 33610. || Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.
Manufacturer
Stryker Spine
1 Event
- Recall of Device Recall Stryker AVS Navigator

Manufacturer

Stryker Spine

Manufacturer Address
Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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