OviTex PRS
TELA Bio, Inc. · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Malvern
- Advisory committee description
- General, Plastic Surgery
- Address 1
- 1 Great Valley Pkwy.
- Address 2
- Suite 24
- Statement or summary
- Summary
- Product code
- FTM
- Zip code
- 19355
- Applicant
- TELA Bio, Inc.
- Decision date
- 2024-05-22
- Decision code
- SESE
- Country code
- US
- Device name
- OviTex PRS
- Advisory committee
- SU
- Contact
- John Urtz
- K number
- K241126
- State
- PA
- Date received
- 2024-04-23
- Review advisory committee
- SU
- Postal code
- 19355
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Mesh, Surgical
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.3300
- Device class
- 2
- Registration number
- 3018094310, 3008868758, 3016823837, 8043792, 3009493875, 1111225, 2244478, 2530154, 3010513348, 3016429246, 3027448274, 2030598, 3013820501, 3012547639, 2132242, 9680579, 3008812560, 3006017180, 2246552, 3010400367, 2249852, 3013666218, 3012448339, 3010155661, 3009039068, 1018470, 9617465, 1835959, 3000931034, 1820334, 2024024, 3010178296, 3003300673, 9615742, 2183620, 3015413883, 3005619880, 1018233, 1550222, 3007321028 +52 more
- FEI number
- 3018094310, 3008868758, 3016823837, 3000303710, 3009493875, 1111225, 3002808269, 3010513348, 1000148471, 3016429246, 3027448274, 3003769549, 3013820501, 3012547639, 3008812560, 3006017180, 3002340648, 2246552, 3010400367, 3000718467, 3013666218, 3012448339, 3002821504, 1000307073, 3010155661, 3009039068, 1018470, 3000931034, 1820334, 2024024, 3003300673, 3003521774, 2183620, 1000518731, 3015413883, 3005619880, 1018233, 1550222, 3008817245, 3007321028 +52 more