510(k) clearances

AlphaVent Knotless SP PEEK Anchor

Stryker Endoscopy · Orthopedic

K233893Substantially EquivalentTraditionalMBI
Open FDA's page for this record
Third party flag
N
City
San Jose
Advisory committee description
Orthopedic
Address 1
5900 Optical Ct.
Statement or summary
Summary
Product code
MBI
Zip code
95138
Applicant
Stryker Endoscopy
Decision date
2024-01-25
Decision code
SESE
Country code
US
Device name
AlphaVent Knotless SP PEEK Anchor
Advisory committee
OR
Contact
Madison Mutchler
K number
K233893
State
CA
Date received
2023-12-08
Review advisory committee
OR
Postal code
95138
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty description
Orthopedic
Regulation number
888.3040
Device class
2
Registration number
3033273526, 3005064037, 3012818475, 3018094310, 3008868758, 3011580264, 3002579136, 8043792, 3014302784, 3021008900, 3032412536, 3007319107, 3017034897, 1835572, 3016926753, 3008837339, 3008262872, 3008749819, 1000484830, 3010047402, 3005381997, 3019807891, 3030514683, 2244478, 3025141, 3007993775, 3005180920, 3032314868, 3013302242, 3006946276, 3010060157, 3013767421, 3016727307, 3006742481, 2530154, 3009826895, 3006108336, 3006981798, 2090040, 3021632375 +237 more
FEI number
3033273526, 3005064037, 3012818475, 3018094310, 1000345108, 3008868758, 3011580264, 3002579136, 3014302784, 3021008900, 3032412536, 3007319107, 3017034897, 3016926753, 3001237338, 3008837339, 3008262872, 3008749819, 1000484830, 3010047402, 3005381997, 3019807891, 3030514683, 3005180920, 3007993775, 1000069183, 3002808269, 3032314868, 3013302242, 3006946276, 3010060157, 3013767421, 3016727307, 3006742481, 3002615969, 3009826895, 1000306303, 3006108336, 3006981798, 3021632375 +237 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.