Synvasive Technology, Inc.
United StatesFDA applicant, unverified
Synvasive Technology, Inc. is a medical device manufacturer, with 263 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) and 4 FDA recalls as of 13 Nov 2026.
- Devices
- 263
- FDA recalls
- 4
Registry facts
- Registries
- FDA GUDID 253
- FDA 510(k) 10
- Device classes
- FDA Class I 256
- FDA Class II 7
- FDA recalls
- Identifiers
- DUNS 968318621
At a glance
Market reach
- United States
- FDA recalls
What Synvasive Technology, Inc. makes
The company manufactures single-use surgical saw blades designed for oscillating and reciprocating applications in orthopedic procedures, including those for knee arthroplasty. It also produces a force sensor balance kit for knee replacements and reusable containers for device sterilization or disinfection. The portfolio includes variants of a branded oscillating saw blade, some of which are intended for preservation or specialized matching applications.
The company’s products are regulated under FDA classifications, with most devices falling into Class I or Class II categories. These devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries.
Catalogue
Search and filter all 263 devicesShowing 1-50 of 263
Company details
- DUNS number
- 968318621
- Phone
- +1(800)348-2759
FDA recalls
FDA recall records list 4 recalls initiated by SYNVASIVE TECHNOLOGY, INC., the earliest on 2013-03-14 and the most recent on 2018-07-27. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 27 Jul 2018 Z-1676-2020 Class II Terminated Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
2015
- 8 Dec 2015 Z-0466-2016 Class II Terminated Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm.
2013
- 2 Apr 2013 Z-1115-2013 Class II Terminated Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
Full distribution text
- 14 Mar 2013 Z-1127-2013 Class II Terminated Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
- 2 Apr 2013 Z-1115-2013 Class II Terminated Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
Frequently asked questions
How many devices does SYNVASIVE TECHNOLOGY, INC. have in the registry?
The registry currently lists 263 devices for SYNVASIVE TECHNOLOGY, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SYNVASIVE TECHNOLOGY, INC.'s devices?
Among its 50 most recently registered devices, SYNVASIVE TECHNOLOGY, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do SYNVASIVE TECHNOLOGY, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for SYNVASIVE TECHNOLOGY, INC.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for SYNVASIVE TECHNOLOGY, INC.?
FDA recall records list 4 recalls initiated by SYNVASIVE TECHNOLOGY, INC., the most recent initiated on 27 Jul 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from SYNVASIVE TECHNOLOGY, INC. in the registry?
The most recently registered devices listed for SYNVASIVE TECHNOLOGY, INC. include 20-8012-010-22, Stablecut® 506138, Stablecut® 11-2238 and eLIBRA® 20-8012-010-16.