Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1216032

FEI Number

1216032

Entity Name

Citra Labs LLC

City/State/Country

Braintree, MA, US

Establishment Address

55 Messina Dr, Braintree, MA 02184, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biomet, Inc. (Owner Number: 1825034)

Owner / Operator Contact Address

56 East Bell Dr., PO Box 587, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AccuFill Bone Substitute Material, AccuFill PreFill ETEX MIXING AND DELIVERY SYSTEM Precision Mixing and Delivery System N-Force Blue Mixing and Delivery System SURGICAL INSTRUMENT BIOMET MANUAL Precision Cannula GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions AccuFill PF CarriGen PF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-06-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-06-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-06-17
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1993-03-18
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-03-23
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2018-03-23
QCG	Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions	Unknown	Class N	N/A	2024-06-17
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-06-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-06-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biomet, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006946279	BIOMET FRANCE	Valence Drome, FR
1825034	BIOMET, INC.	WARSAW, IN, US
3006801265	Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, CN
3002806535	BIOMET UK LTD.	BRIDGEND, GB
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K983036	Biomet, Inc.	SINGLE AXLE TOTAL ELBOW	1999-04-30
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08
K921181	Biomet, Inc.	MALLORY-HEAD TOTAL HIP SYSTEM	1994-02-16
K830313	Biomet, Inc.	CFE TOTAL HIP FEMORAL COMPONENT	1983-05-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0032-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
Z-0033-2009	Biomet, Inc.	2	Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1216032. Last updated year: 2026. Please use registration number 1216032 when referencing this establishment in official correspondence.