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Sign in to claim this brandSYNVASIVE TECHNOLOGY, INC.
US
Last updated May 24, 2026
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. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zimmer.com
- —
- —
- [email protected]
- Phone
- +1(800)348-2759
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 968318621
Catalogue (261)
Page 5 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Neo Classic™ | 20-8012-010-43 | FDA UDI | Class I | Active |
| Stablecut® | 11-3764 | FDA UDI | Class I | Active |
| Stablecut® TruMatch™ | 562710552 | FDA UDI | Class I | Active |
| eLIBRA® | 20-8012-000-01 | FDA UDI | Class II | Active |
| Stablecut® | 562782601 | FDA UDI | Class I | Active |
| Stablecut® PFC Sigma™ | 562710601 | FDA UDI | Class I | Active |
| Stablecut® | 964001100 | FDA UDI | Class I | Active |
| Stablecut® | 11-3732 | FDA UDI | Class I | Unknown |
| eLIBRA® | 20-8012-010-29 | FDA UDI | Class I | Active |
| Stablecut® AMK® | 562744601 | FDA UDI | Class I | Active |
| Stablecut® | 11-3759 | FDA UDI | Class I | Active |
| Stablecut® | 11-2618 | FDA UDI | Class I | Active |
| Stablecut® | 506131 | FDA UDI | Class I | Active |
| Stablecut® | 506299 | FDA UDI | Class I | Active |
| Neo Classic™ | 20-8012-010-39 | FDA UDI | Class I | Active |
| Neo Classic™ | 20-8012-010-46 | FDA UDI | Class I | Active |
| Stablecut® | 516014 | FDA UDI | Class I | Active |
| Stablecut® AMK® | 562739000 | FDA UDI | Class I | Active |
| Stablecut® | 950501596 | FDA UDI | Class I | Active |
| Stablecut® TruMatch™ | 562714550 | FDA UDI | Class I | Active |
| Stablecut® | 506113 | FDA UDI | Class I | Active |
| Stablecut® AMK® | 562743601 | FDA UDI | Class I | Active |
| Stablecut® | 11-3586 | FDA UDI | Class I | Active |
| Stablecut® | 11-4024 | FDA UDI | Class I | Active |
| Stablecut® | 11-2222 | FDA UDI | Class I | Active |
| Stablecut® | 950501595 | FDA UDI | Class I | Active |
| Stablecut® | 506093 | FDA UDI | Class I | Active |
| Libra | 20-8012-010-05 | FDA UDI | Class I | Active |
| Libra | 20-8012-001-01 | FDA UDI | Class I | Active |
| Stablecut® | 11-3655 | FDA UDI | Class I | Active |
| Stablecut® | 11-3944 | FDA UDI | Class I | Active |
| Neo Classic™ | 20-8012-010-47 | FDA UDI | Class I | Active |
| Stablecut® | 11-3582 | FDA UDI | Class I | Active |
| Stablecut® | 506112 | FDA UDI | Class I | Active |
| Stablecut® | 223000268 | FDA UDI | Class I | Active |
| Stablecut® | 11-4681 | FDA UDI | Class I | Active |
| Stablecut® AMK® | 562743000 | FDA UDI | Class I | Active |
| Stablecut® | 11-3997 | FDA UDI | Class I | Active |
| Stablecut® | 11-2739 | FDA UDI | Class I | Active |
| Stablecut® | 506122 | FDA UDI | Class I | Active |
| Stablecut® | 11-2217 | FDA UDI | Class I | Active |
| Stablecut® | 223000263 | FDA UDI | Class I | Active |
| Stablecut® | 11-3656 | FDA UDI | Class I | Active |
| Stablecut® | 11-3987 | FDA UDI | Class I | Active |
| Stablecut® TruMatch™ | 562714552 | FDA UDI | Class I | Active |
| Stablecut® | 964027000 | FDA UDI | Class I | Active |
| Libra | 20-8012-001-00 | FDA UDI | Class I | Active |
| Stablecut® | 506078 | FDA UDI | Class I | Active |
| Stablecut® | 855540012 | FDA UDI | Class I | Active |
| Stablecut® | 223000270 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
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Authorities
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Synvasive Technology, Inc. has four recall records initiated between March 14, 2013, and July 27, 2018, all of which are marked as terminated. The recalls involve mislabeling and incorrect identification of oscillating and reciprocating saw blades, including discrepancies in blade width specifications (25 mm instead of 19 mm), incorrect product descriptions on pouches, mismatched barcode and expiration dates, and incorrect blade type labeling.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 27, 2018 | Z-1676-2020 | — | terminated | Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. |
| Dec 8, 2015 | Z-0466-2016 | — | terminated | Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm. |
| Apr 2, 2013 | Z-1115-2013 | — | 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. |
| Mar 14, 2013 | Z-1127-2013 | — | terminated | Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade. |