Augment Off-Axis Instrument System
Fix Surgical · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Conshohocken
- Advisory committee description
- Orthopedic
- Address 1
- 425 Fayette St.
- Address 2
- #617
- Statement or summary
- Summary
- Product code
- PHX
- Zip code
- 19428
- Applicant
- Fix Surgical
- Decision date
- 2024-05-15
- Decision code
- SESE
- Country code
- US
- Device name
- Augment Off-Axis Instrument System
- Advisory committee
- OR
- Contact
- Brian Karpinski
- K number
- K241043
- State
- PA
- Date received
- 2024-04-17
- Review advisory committee
- OR
- Postal code
- 19428
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Shoulder Prosthesis, Reverse Configuration
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3660
- Device class
- 2
- Registration number
- 3012818475, 3008868758, 1822565, 3009185591, 3002579136, 8043792, 3014302784, 3010287737, 3014833750, 3021008900, 3033273230, 3006356043, 1835572, 1226544, 3019807891, 3002806603, 3006801265, 3010047402, 3007051929, 3013194153, 3005180920, 2244478, 1644408, 3006946276, 3013302242, 3009887475, 3015806723, 3010065126, 9613350, 3004976965, 3012552981, 3008395353, 3009871135, 3033509898, 3006984710, 3006017180, 3002807310, 3003998208, 3005596372, 3010400367 +153 more
- FEI number
- 3012818475, 3008868758, 3009185591, 3002579136, 3014833750, 3014302784, 3010287737, 3021008900, 3033273230, 3002807036, 3006356043, 3019807891, 3002806603, 3006801265, 3010047402, 3007051929, 3013194153, 3005180920, 3002808269, 3006946276, 3013302242, 1000306303, 1000199976, 3003414678, 3009887475, 3003015552, 3015806723, 3010065126, 3004976965, 3012552981, 3008395353, 3009871135, 3002924544, 3000206435, 3006017180, 3033509898, 3006984710, 3003386935, 3002807310, 3003998208 +153 more